Tuesday, July 8, 2008

Tendon rupture with Cipro? FDA caves to Public Citizen

Once again, in an attempt to show strength in its ability to protect the public, the FDA shows its weakness by caving to Public Citizen (a group that clearly hates the pharmaceutical industry) by placing a boxed warning on fluroquinolone antibiotics like Cipro and Levaquin.

What's the concern?
According to the FDA:
"Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy."
Tendinitis and tendon rupture are usually associated with sports injuries with younger people. The mechanism by which these antibiotics cause tendon problems remains a mystery.

How serious is this?
On the one hand, these problems are not life threatening. However, they can cause severe pain and disability. As far as warnings go; however, a boxed warning is a pretty serious warning. I have posted previously on the FDA's different levels of warnings. (Note: There is no such thing as a "Black Box", it is a boxed warning. The "black" is something scary the media added). Tendon rupture had been mentioned in these antibiotic's label as an adverse event, so by adding the boxed warning, the FDA is stating this is a greater concern.

So if the problem is serious, why is the warning a bad thing?
According to the Washington Post, The FDA's action came after the consumer group Public Citizen petitioned and later sued the agency for such warnings. Public Citizen's review of the adverse events from November 1997 through Dec. 31, 2005 showed 262 reported cases of tendon ruptures, 258 cases of tendinitis, and 274 cases of other tendon disorders. This is a ridiculously low number if one considers the millions and millions of prescriptions that have been written for quinolone antibiotics such as Cipro. The FDA stated it had recently done its own "new" analysis, which is why it added the boxed warning. However, they do not present the details of their findings. To me, this implies that they simply caved from public pressure and/or from law suit threats. This is a problem, because so many patients who have or will have taken these medications will be needlessly worried. Even worse, some patients might simply stop taking their antibiotics. Finally, further hype regarding drug dangers continues to create an unnecessary fear about medications among the public. This is evident with publications like the "8 drugs doctors would never take" which I previously blogged about, later showing that when you asked real doctors, they completely disagreed (I will follow up on this post shortly).
In my opinion, the FDA showed similar weakness in response to the Avandia hype. As I have blogged previously, based on data they had at the time, and even more recent data, the risk of heart attacks and Avandia just doesn't seem to be true. Yet, the FDA changed its label, scaring and confusing patients and physicians. (The recent recommendations about approval of future diabetes drugs are similar actions).

Bottom Line
One thing that shouldn't be overlooked is that despite my opinion that the boxed warning is likely unnecessary and unhelpful, quinolone antibiotics are over-prescribed. A once powerful drug, many bacteria are now resistant to Cipro because of over-use. Newer generations of fluroquinolones are likely similarly over-prescribes (as are antibiotics in general). That said, there are some conditions mild (uncomplicated urinary tract infections) and more serious (pneumonia) where therapy is appropriate. In those cases, these medications should be used. The boxed warning should be taken into consideration (consider alternatives for elderly and immunosuppressed patients and/or warn appropriately), but for the general public, tendinitis and tendon rupture was so rare, even by Public Citizen's numbers, that this should still be considered a rare adverse event.

159 comments:

david t fuller said...

Your comments mirror the rampant ignorance found within the medical community regarding the true safety profile of this class. The true incident of such ruptures remains an unknown due to clueless physicians failing to associate such a event with fluoroquinolone therapy, and then failing to even report it when it takes place. The FDA did not 'cave in' to Public Citizen as you are claiming but in fact issued a warning that has been long overdue, a warning they have recieved three seperate petitions with the first filed in 1996, filed by Public Citizen, the second in 2005, filed by the Attorney General of the State of Illinois, and the third once again by Public Citizen. For more than a decade now the FDA has done little to nothing to warn the patients. It was only after they had been sued for FAILING TO REVIEW THESE PETITIONS AS REQUIRED BY LAW do we see anything being done. I would suggest you read the articles found in the leading medical journals concerning these issues before commenting upon them. You would be amazed at how deadly this class is. Spontaneous tendon rupture is the least of the patient's concern. The fact that more than half of these drugs have been removed from clinical practice due to severe toxicity issues including fatalities seems to have escaped your notice.

Leslea Bates said...

I am part of the medical community and have been part of it for almost 30 years. I am amazed at how uninformed physicians are about the quinolone class of antibiotics and the damage they can do. Since I am well respected as a medical professional, I have informed many physicians of the permanent damage I am suffering from, all due to a quinolone. I also enlighten them as to how often this happens and how many times it is overlooked as an adr to a quinolone.
What is really incredulous is that I find quinolones being prescribed when there are many other antibiotics that will work as well that don't cause as many problems for the patient or lead to as many bacteria becoming antibiotic resistant.
Dr. Mintz, please open your eyes, the thousands and thousands of us that are suffering and many of us that have permanent damage are not a figment of anyone's imagination including our own. These adr's are way under reported, under recognized and pretty well ignored by physicians and the pharmaceutical companies. Some physicians just seem to find it easier to just use the same antibiotic for everyone rather than look at an antibiogram for the most effective and safest antibiotic available.
These antibiotics are dangerous for a much larger percentage of the population than will probably ever be realized, if the true number of quinolone adr's were reported I think you would change your attitude towards this class of drugs and be more apt to prescribe something else. After all didn't you take an oath to "do no harm" ? If you take that oath seriously maybe you should research your viewpoint and make sure it is valid, those of us that have suffered due to the quinolones know the real statistics and want to inform others so that they won't end up like us.
As a medical professional I challenge you to really look at this issue with an open mind and really pay attention to patients that have been given quinolones, ask them if they have any joint pain, any skin changes, any vision changes, any unexplained depression, sudden onset of short term memory loss, numbness in their extremities, nerve pain that might present itself as burning or shooting pains down their arms or legs. I could go on and on, but I think you get the picture. And that is just the non-lethal reactions that are not recognized. Many people have died because of quinolones also.
Wake up medical community pay attention to your patients and what you are doing to us.

Dr. Matthew Mintz said...

All antibiotics (and medications for that matter) have side effects. The question at hand is are fluoroquinolones relatively safe and effective antibiotics compared to other antibiotics, and is this new warning cause for alarm and panic.
As stated in my original post, I believe that antibiotics and quinolones in particular are overused. However, from a safety standpoint the class seems to have a relatively good efficacy to safety balance (when used appropriately) and it doesn't appear to me that the boxed warning and media attention accompanying it should raise major concerns for patients.
1. There are many adverse events associated with quinolones. The boxed warning is only regarding tendonitis and tendon rupture. There is no question that the adverse event reporting system underestimates true events. However, even if the rates were 5 times higher than reported, they would still be low. Rather than try to scare the public, I would argue that the FDA ought to devote resources to improving the adverse event reporting system.
2. Quinolones do indeed have adverse events, and some of them serious. There is simply no perfectly safe medicine. Antibiotics, though overused, are in fact needed on occaision. One of the reasons that life expectancy has increased over time is due to antibiotics. If you compare the quinolones to other classes of antibiotics, they are not substantially more dangerous as the boxed warning and media attention would suggest.
3. Not all quinolones are alike. Gatifloxacin (Tequin) and Trovafloxacin (Trovan) are examples of unsafe quinolones, and there is certainly literature on these adverse effects. Maybe I should have been more clear in my orginal post, but the point of my post is to calm any unnecessary fears about more commonly used quinolones such as Cipro, that are often the first line recommendation for some infections.
4. I have researched the literature on adverse events with quinolones. As above they are not all the same. There are several Cochrane reviews and a publication in American Family Physician. Indeed their are some side effects, but I wouldn't characterize these drugs as substantially more dangerous than other antibiotics.
5. It is horrible when patients experience adverse events from medications. The down side of utilizing medications to treat illnesses is that some patients will get harmed. David, it sounds like your experience with quinolones was horrible, which is why I guess you are writing a book about it. I am sure the same is true for Leslea and Seena. I am sure that if I had a bad reaction to Cipro, I might feel differently as well. The problem is that if you start giving any medication to millions of people, hunders and even thousands may have bad outcomes. The issue is when my 50 year old patient with emphysema comes in my office for pneumonia, and I prescribe Levaquin (which is recommended by most guidelines), he may refuse to take this and get sicker because of unnecessary fear provoked by Public Citizen and the media.

Anonymous said...

Severe toxicity is not a "side-effect"....it's a death sentence.

Mary (frances hunter too) said...

Dr. Mintz, this is a matter of providing adequate information and protection to the public. Last year, I went in to the urgent care clinic for a case of strep throat. I left with a paper bag of samples of Levaquin -- and no pharmaceutical fact sheet, no side effect warnings, nothing. I did my research prior to taking the drug and was surprised by the anti-fluoroquinolone ravings, but I decided to trust the medical establishment and took it anyway. I was in my 30's, healthy, and had never had a bad reaction to any drug before.

After a few days, when I started having shooting, burning pains in my hips, knees, and ankles, I knew enough to quit taking the drug. Five days on Levaquin left me with severe pain and stiffness in my legs and feet. I was seriously crippled for about two weeks. The worst side effect was terror-- that I would never be the same again.

I count myself lucky. Most of the pain slowly faded away within a few months, and I gradually regained most (but not all) of the strength and flexibility in my legs. One year later, I still have some minor but noticeable pain and stiffness in my ankles as a result of taking this drug.

The point is not whether the drugs are effective -- yeah, while Levaquin was crippling me, it got rid of my strep throat. The point is that a patient should not have to risk being disabled when they go to the doctor to seek treatment for a fairly routine infection. I applaud the FDA's action and just wish they'd done it sooner.

Shelley Sealover said...

THE ISSUE IS: when ANY patient (any age) comes into a doctor's office w/ a sinus infection, bladder or urinary tract infection, upper respiratory infection...he/she is NEVER prescribed a powerful, toxic antibiotic that would cripple or maime and cause severe disabling suffering for the rest of his/her life.

"Unnecessary fear", doctor?????
Think again.

Anonymous said...

Rare side effects rarely ocurring... but the makers of quinolones or the FDA are clueless about the psychological side effects as well. I have been to over two dozen doctors who can't find a drug or a therapy who can eliminate these 'side effects'. Great medical coverage - utterly useless if you've been poisoned by Cipro.

see my blog deathbycipro.wordpress.com and see if rarely ocurrs makes a difference if you are poisoned by Cipro.

Anonymous said...

Dr. Mintz, you are severely uninformed about these drugs. I was a healthy 40 year old who had never had a reaction to any drug previously. A 10-day prescription of Levaquin 500 mg for pneumonia completely changed my life. I have lived with crippling pain and neuropathy for more than six months because of this poison. The thing I want to point out is that I had a DELAYED reaction. I suspected my symptoms were caused by the drug; but when I began researching side effects of fluoroquinolones, I confirmed my suspicions when I found thousands of others suffering from the same problems I was suffering from. Imagine how many others are suffering who have not connected their pain with the drug because they had a delayed reaction. Or, imagine all the people who are suffering who do not have the internet or access to this information. No, these are not rare reactions. I personally know more than 10 people who have had a bad reaction to a fluoroquinolone antibiotic. These are people around me, not people I've met online. Unfortunately what it's going to take for the medical community to become believers is for this to happen to you or someone you love. Maybe you should just stay clear of the fluoroquinolones to be safe...

ciprovictimalso said...

How I wished that there had been a black box warning long ago. My husband was in his early 40's in 1998. That's when he was first prescribed Cipro. About a month later he thought he was developing rheumatoid arthritis. He thought his health was deteriating because of working too hard all his life. There were other adverse reactions that occurred also. Insomnia, panic attacks, suicidal thoughts and actions are just a few he developed after taking Cipro. Around 11 months after taking Cipro a rupture occurred in his left calf in 1999. In 2000, he had a rupture in his right knee and in 2001 a rupture in the middle of his right thigh. He had seen several different doctors by this time. Not 1 of them made the connection between Cipro and tendon ruptures. He also developed tendonitis, sometimes the right arm, sometimes the left arm and sometimes both arms at the same time. For the next few years he didn't have any more rupturing to occur. In 2004, he was prescribed Cipro for the second time. He took it all. Around 11 months later a rupture occurred in his right elbow in 2005. He had 3 ruptures involving both his arms in 2005. He used to tell me before 2005 that as long as he had 2 good arms left that he would make a living for his family. He was a former Marine and in great physical condition before Cipro. Now he's crippled. Our grandchildren are stronger than he is. They are 6 and 7 years old. Can you imagine that. By now, I have taken him to see almost a dozen different doctors, but not 1 of them ever made the connection between Cipro and tendon ruptures. A doctor asked me if my husband had ever been exposed to agent orange when he was on active duty in the Marine Corps. My husband wasn't, but that changed my search for what was causing his condition. For years I had been looking for answers using the Internet to find the cause of his declining health. I was begging doctors to please find out what was happening to him. In 2006, I found the connection between Cipro and his injuries. A healthy man had 6 ruptures in his body and not a single doctor knew why. So if a person has only 1 or 2 ruptures caused by quinolones, I'm quite sure the doctors won't know the cause and it won't get reported. My husband's a human being who didn't deserve this. The sad thing is, he's not alone. So many people's health has been affected by these medicines, but even worse than this are those who have no idea what is causing their declining health nor do their doctors know.

david t fuller said...

Yes doctor you could consider being both blinded and crippled by a drug (floxin, cipro and levaquin) to leave a 'bad taste' in one's mouth. Especially when they were prescribed for a kidney stone rather than a life threatening bacterial infection. In fact there never was an infection to begin with. What you continue to fail to grasp is not only how frequent such events take place in reality, but the severity of the damage when they do. NOBODY should risk being crippled for life to treat a common infection that just about any other antibiotic could handle in a much safer manner WITHOUT BEING INFORMED OF THIS RISK in advance. Failure to warn and failure to engage in a meaningful risk/benefit discussion beforehand is what I take grave exception to NOT being done.

Had I been informed of these risk I would have refused to take the medication. To add insult to my injuries is for the treating physician(s) to DENY what had happened to me was in anyway related to the drug he prescribed, for over eight years. This is what I find to be unforgiveable. The rampant ignorance and arrogance found within the medical community when they find that thier favorite toy is killing and crippling more people than it is saving.

Again I beg you to read the medical journal entries found on the research site as well as the tens of thousands of postings found on the discussion forums, rather than the blantantly false information being provided by the drug companies.

I fully understand and even appreciate the neccessity of such a dangerous drug in your arsenal. Sometimes it truly is a matter of life and death or loss of limb. Then AND ONLY THEN should you reach for this drug. But the reality is that this is the FIRST drug prescribed rather than the more appropriate and safer alternatives. More than 10% of the world's population has been prescribed a fluoroquinolone drug. Well over 600 million patients. In reality, with an adr rate in excess of 40%, as found within the NDA for levaquin alone, you are looking at millions upon millions of misdiagnosis patients whose bodies have been ravaged by these drugs and the clueless physician attributes this to ANYTHING BUT the fluoroquinolones.

With all due respect sir, this is unforgiveable and totally unacceptable. More than half of these drugs have NOT been removed from clinical practice because they are too safe, but because they killed and cripple far too many patients.

There is little to no difference in the pharmcore of these drugs as they are all based upon the quinolone ring and these serious reactions are a class affect. Liver, heart and kidney damage, SJS and TENS, destruction of the muscles, ligaments and tendons, hypo and hyperglycemia, irreversible peripheral nueropathy, etc., have ALL been reported with ALL THE DRUGS IN THIS CLASS. To deny this reality is to live in a fantasy world. And the last thing I want is someone who denies reality to be educating potential physicians. Listen to the patients doctor and ignore the drug companies propaganda. You will be a much better physician for doing so.

If you would be kind enough to indulge me further I would like to share with you an excerpt from 62nd Anti Infective Advisory Hearing held almost a decade ago:
"…when we talk about the issue of arthropathy that potentially includes a number of things, ranging from simple effusion, for instance, of a knee joint, which might rapidly resolve after the conclusion of therapy, to a more permanent disability. .." (sic)
"…in September of 1997 there is now a ciprofloxacin suspension which is available, and although it continues to have the same warning statements about arthropathy in juvenile animals and the potential concern in pediatric populations, obviously, the issue of off label use will extend over to pediatric populations in this formulation…."(sic)
"…An important safety question is, what adverse events should be monitored, and Doctor Goldberger alluded to this earlier. This is some of the examples I present. One is permanent lameness, reversible lameness, joint effusion, joint pain, and even latent articular disease or damage that may occur months or years following drug exposure, and there may be others…."(sic)
"…And, data submitted to the Agency, as well as data from the scientific literature, indicate that these lesions don't appear to be reversible…"(sic)
"…Doctor Stahlmann in Berlin is working on an idea that it may be an effect between the endocrines, the magnesium and the matrix and the quinolone. And that data is just coming out now. But as to the exact mechanism, I think you're right. I don't think we have a handle, as far as I know, on the exact mechanism. If there's anybody else that does, I'd sure like to hear it…"(sic)
"… Relating your personal experience, I was wondering about the potential for a delayed effect that in fact one might have a patient who had some histologic changes that would not be manifest clinically for many years. Is that a potential?" (sic)
"… I think it is a potential…"(sic)
"… In trying to assess toxicity with a very sensitive assay, obviously you've got tissue that you can look at in your animal models. There is some human data that were collected by Doctor Urs Schaad using MRI scanning in children and I'm wondering if you can correlate some of your histopathologic findings with MR in the animal model to give us an idea of how sensitive it would be sort of as a follow-up to Doctor Klein's question is the MR something that will be able to predict long-term outcomes, even if there are no clinical symptoms during therapy…."(sic)
"… That I don't know. I'll just be perfectly frank. I don't know. But on the slides I've seen from the animals from the chronic study, the repaired articular cartilage that is there is principally fibrocartilage yet it will provide the same joint margin and it has a calcified base and when we stain it with safrain O screen there's no proteoglycans there so it's going to make it an extremely chondromalaistic area and beyond the one year I can't tell you what the results will be…"(sic)
"…Anyway, it was by a group in Vienna where they looked at the articular cartilage of postmortem specimens of articular cartilage from kids with cystic fibrosis that had been on quinolones for a period of time and they found that there was damage in the chondrocytes…."(sic)
"…There were no deaths reported in U.S. pediatric zero to 18 year old cases where a flouroquinolone was reported as the suspect drug. However, there are eight deaths in the whole cohort of suspect and concomitant flouroquinolone drug reports in the system. Five of these deaths reported ciprofloxacin as a concomitant drug and not the suspect drug. These five were U.S. cases with ages ranging from seven months to six years. The remaining three deaths were all foreign, all 18 year old patients with either ofloxacin or norfloxacin reported as the suspect drug…."(sic)
"…There are 14 reports of arthropathy or arthralgia in the pediatric zero to 18 year old flouroquinolone reports. One report of a 14 year old girl had both ofloxacin and lomefloxacin as the suspect drug so there is an extra count because of the two flouroquinolones on this one report. This particular report indicates that a pediatric orthopedic surgeon diagnosed femoral anteversion as the cause for the girl's arthralgia, therefore you see it listed twice, and not the flouroquinolones. Most of the reports indicated that either an involved knee or elbow with or without other joints was involved…."(sic)
"…One interesting case which is not included on this slide for arthralgias was a 15 year old boy who received ofloxacin IV for an emergency appendectomy and had not grown more than his 70 inches in height over the last year. The 15th percentile for height for a 15 year old boy however is 66.5 inches and the expected growth rate is about two inches per year…"(sic)
"…Three patients had their seizure after the first dose of flouroquinolone, one on ciprofloxacin and the other two on ofloxacin, one of which had received ofloxacin several months earlier…"(sic)
"…The 15 psychiatric reports are a loose grouping of reports which include events ranging from euphoria to psychosis. The ages range from five to 18 years with the median at 15 years. There were two suicide attempts, one on ofloxacin and the other on norfloxacin, three reports of hallucination, one each on ciprofloxacin, ofloxacin and norfloxacin, and one report of aggressive behavior with confusion in a patient who had a psychiatric history and was on norfloxacin. The seven cases of photosensitivity were reported with lomefloxacin with one case on ciprofloxacin and two cases on ofloxacin. …"(sic)
"…I will mention that there were 152 U.S. cases aged zero to 18 years in the U.S. AERS system suspect flouroquinolones in the WHO line listing. The country with the most pediatric reports in the WHO foreign reports is the United Kingdom with 177 reports followed by Germany with 72 and France with 71. The rest of the countries had 20 or fewer reports…."(sic)
"…And with regards to muscular-skeletal events, 21 percent of the patients had an event in ciprofloxacin…"(sic)
"…We have focused our analysis on joint disorders and pefloxacin. 79 cases were reported and consist mainly of arthralgia. I don't know the pronunciation of hydrarthrosis -- 49 persons. It involved the knee in 52 cases, the wrist in 20 cases, the elbow in 20 cases, the shoulder in 6 cases, the ankle in 5 cases, and the hip once. It is associated with a functional discomfort in all cases, and when the duration of this discomfort is known, it can persist more than one month in 61 percent of these cases. But the outcome was favorable in 58 cases without discontinuation in two cases. …"(sic)
"…There have been sequelae in three cases with knee effusions persisting one year later in one case with discomfort following 8 months later in the second case. The third case is articular. It is a 17-year-old patient who experienced arthropathy and the drug was not suspected and the treatment was continued two following months. It leads to destructive arthropathy of the knees and the hip and prothesis was performed three years later. He was treated for a cerebral abscess. The outcome was unknown in 18 cases. In 9 cases, there was no follow-up. In the 9 last cases, we had a follow-up three months later and patients were not -- were still with disabilities and after we have no evolution…." (sic)
"… It is my understanding that one of the children had a joint replacement, is that correct?"
" Pardon me?"
" One of the children with the complications had an artificial joint replacement?"
"Yes."
"…If an irreversible cartilaginous lesion can occur, it is very likely that is going to cause problems down the line and we can't even anticipate what they are like…" (sic)


Rather than continue to debate this with you as surely my words have made no impact on you, I will leave you in peace with this final statement:

First, do no harm. Remember this the next time you reach in your black bag to write a frivolous script for a fluoroquinolone drug when a much safer alternative exist. Your patient will thank you for this courteousy. So will your malpractice insurance carriers.

Todd Plumb MD said...

Dr. Mintz,
I am a physician and I would have agreed with your post 2 years ago before I suffered a severe adverse reaction to levaquin. The true incidence of adverse reactions is unknown. The FDA bases its reporting on an antiquated system of which most doctors are unaware. Medwatch is speculated to capture less than 3% of reportable reactions. Drug studies of antibiotic reactions are funded by the very companies that would be implicated if adverse events were found. There is no such thing as unbiased drug research in the USA, and so your investigation of side effects related to this class is analogous to going to tobacco companies in the 1970s to ask them if cigarettes caused cancer and believing them when they said no. In my practice I have helped to care for more that 50 patients with adverse reactions ranging from CNS issues, tendononpathy, tendon rupture, peripheral neuropathy, and many other issues. The FACT is that the true incidence of serious fluoroquinolone reactons is unknown but if you fail to recognize the large groundswell of chronically inujured patients who attribute their disabities to fluorquinolones than your are ignoring the maxim to, "first do no harm".

Dr. Matthew Mintz said...

There is clearly a strong reaction to this post, which at a minimum shows me that people are reading my blog. I appreciate the concern that so many of you express for others, and will at least agree that clearly more investigation on the safety of this class of medication is warranted.
My post was not intended to defend Cipro or the quinolone class, but rather a criticism of the FDA.
Again:
1. Quinolones are clearly overused. They should not be prescribed for strep throat and other commone infections. I honestly rarely use this class of medications.
2. I do not deny that some of the very serious adverse effects mentioned may have been due to quinolones.
3. Physicians clearly should warn patients about side effects of any medication.

However...
Many of the adverse events mentioned in these comments are neurologic, muscle, psychological and use terms like "cripple." The boxed warning was specifically due to tendonitis and tendon rupture, and specifically in vulnerable poputlations. This adverse effect is already mentioned in the package insert. My question is "what changed?"
The incidence of Achille's tendon ruptuer in the general population is about 1/100,000. Quinolones may increase this risk by 3 or 4 times, but that still only 4/100,000 which is pretty low. As above the data presented by Public Citizen is similarly low. (Also, if all these other side effects are more common then stated and quinolones should be banned or severely restricted, why is this not showing up in Public Citizen's analysis?)
Why did the FDA sit on their petition for years and then suddenly add a box warning? They said they have a new analysis, but where is the data? In my opinion, the FDA (rightly or wrongly) is coming under intense criticism, and in an effort to save are taking actions that appear to be "cracking down" on the drug safety, but in reality are not doing much of anything, and in fact may be scaring and possibly harming patients.

Below are links to the package inserts for both Cipro and Augmentin (amoxicillin/clavulinic acid). If you look at the adverse events, precautions and warning of Augmentin, it looks almost as scary as Cipro.

Quinolones are currently recommended as first line therapy for complicated urinary tract infections, community acquired pneumonia in patients with diabetes or lung disease, community acquired/traveler's diarrhea and to be given before certain urologic procedures.

For patients with the above conditions, should they not take Cipro? No question there may be some serious adverse effects (and again, maybe further investigation is warranted). However, should they take something else like Augmentin instead (which also has some pretty scary looking side effects), when Cipro is preferred for these conditions?
I am still of the opinion that there is really nothing new found by the FDA or Public Citizen to warrant going against the guidelines.

Rather than add a boxed warning which is sure to pick up media attention (even if no new data is presented to doctors or patients), the public would be better served by the FDA actually looking into adverse events. There is not question that the current system is inadequate. Wouldn't the public be better served by the FDA focusing its attention on trying to fix it? As one commentor mentioned, almost all the data is from the drug companies. This is true. Shouldn't the FDA lobby to get funding to sponsor studies not funded by the pharmaceutical industry?

Cipro PI

AugmentinPI

John P Slone, PhD said...

Dr Mintz

As yet another person who experienced a severe ADR from a fluoroquinolone, I find myself wanting to both applaud and criticize this action by the FDA. While I agree with your assertion that this particular warning fails to mention many of the serious reactions that can occur, and that the public would be better served by an improved reporting system, I disagree with your conclusion that a boxed warning is unhelpful.

In my particular case, I presented with symptoms of sinusitis roughly five months ago, and was prescribed Levaquin as the first line of defense. I was also taking a corticosteroid and probenecid (which has been demonstrated to reduce the renal clearance rate of Levaquin by 33%, in effect mimicking a degree of renal insufficiency). In addition, for reasons I won’t explain at this time, my physician had reason to believe at that time that the infectious agent was likely to be a strain of methicillin resistant staphylococcus aureus (MRSA), so she obtained a sample to be cultured during the same visit during which I was prescribed the Levaquin. As it turned out, the culture indicated a heavy growth of MRSA, so I was instructed to switch to a different antibiotic. Two days after that (i.e., two days after I stopped taking Levaquin), I woke up experiencing severe pain in multiple joints throughout my body. I have not experienced any ruptured tendons (yet), but I am still dealing with the pain on a daily basis, I am unable to walk more than a few yards without a cane, and I am facing a future with a highly uncertain prognosis.

So, I ask you: given that the boxed warning would have failed to predict my specific reactions, does that mean that the existence of such a warning would have been unhelpful to me? To the contrary, I submit that it would have made all the difference in the world. First, recognizing that there was significant suspicion that the bacteria was resistant to fluoroquinolones, the extra awareness brought about by a boxed warning would certainly draw into question the appropriateness of prescribing this class of drugs first. Second, the specific mention of both corticosteroids and renal insufficiency would have amplified the concern. Under these circumstances, I doubt very seriously that my physician would have prescribed the same course of treatment.

Do I advocate removing this class of drugs from the market? In the absence of better data, no. However, I strongly advocate the reconsideration of whether the dangers of this drug warrant its widespread use as a first line of defense.

In the meantime, I urge you to think twice before dismissing this (or any other) boxed warning as the mere “caving” of an ineffective bureaucracy.

Dr. Matthew Mintz said...

Dr. Stone,
I am sorry that you are having such a rought time. Not sure what your PhD is in, but as a researcher or scientist, I am sure you realize that though you condition might have been caused by the Levaquin, it may have been caused by the other antibiotics, MRSA, your underlying condition, or something else.
Quinolones should not be used as first line for sinusitis. (Bactrim, an underused old and still effective drug is resistant to MRSA in general, so that would have been a much better choice).
I suppose a box warning may have caused your physician to think, "now should I really be using Levaquin?," but it shouldn't take a warning about adverse events for physicians to use medications appropriately. In addition, the box warning may cause a physician to underutilize a quinolone in the appropriate situation, choosing a less effective agent instead. (Boxed warnings on Avandia and Advair have scared physician away from using these products often leading to use of less effective agents in the later case, and no agent in the former-recent data suggests these fears are unwarranted).
Again, the boxed warning and the Public Citizen petition has nothing to do with arthritis or arthalgias, but tendonitis and tendon rupture.
If the adverse events causes by the quinolones (tendon isssues and others) are truly worse then initially thought, then a thorough investigation is warranted. However, I have not seen data to substantiate this, and can not practice medicine based on isolated anecdotal reports. The FDA would better serve the public by leading or asking for such an investigation, rather than placing a boxed warning due to a rare adverse event without a good explanation of why a box warning is being placed now.

John P Slone, PhD said...

Dr. Mintz,

Thank you for your comments. Interestingly, my research is in the area of "information quality", which is, in effect, what this discussion is really all about. There is a vigorous debate within that research community about the relative merits of qualitative versus quantitative methodologies for assessing the quality of information. As the fluoroquinolone debate points out, there is no easy answer.

Having said that, I fully concur that the causality of my condition cannot be established conclusively. Nonetheless, there is a substantial and growing body of both anecdotal and stochastic evidence to support the conclusion of my orthopedist, who told me that "Levaquin is at least as likely as any other explanation".

There's much more to my story, but that's not the point. One thing I think we both would agree on is that much better information is needed. What we don't seem to agree on is whether the relatively poor information provided by a box warning is better or worse than the information provided by text that appears without the highlighting provided by the box.

david t fuller said...

"The incidence of Achille's tendon ruptuer in the general population is about 1/100,000. Quinolones may increase this risk by 3 or 4 times, but that still only 4/100,000 which is pretty low." Wrong again.

Citing to the following studies:

J Heart Lung Transplant. 2008 Jan;27(1):46-51.

Quinolone-related Achilles tendinopathy in heart transplant patients: incidence and risk factors.
Barge-Caballero E, Crespo-Leiro MG, Paniagua-Martín MJ, Muñiz J, Naya C, Bouzas-Mosquera A, Piñón-Esteban P, Marzoa-Rivas R, Pazos-López P, Cursack GC, Cuenca-Castillo JJ, Castro-Beiras A.

"5.8%; 95% confidence interval" (that is 6 out of 100.)
******************
Fluoroquinolones-induced tendinitis and tendon rupture in kidney transplant recipients: 2 cases and a review of the literature.
Muzi F, Gravante G, Tati E, Tati G.
Department of Oncologic Urology, S. Eugenio Hospital, Rome, Italy.
The incidence is 0.14% to 0.4% but, in the kidney recipient population, the phenomenon is even more common (incidence, 12.2%-15.6%). (Here we are looking at .4% or 16 out of a hundred.)
************************
Evidence of tendinitis provoked by fluoroquinolone treatment : a case-control study. Corrao G, Zambon A, Bertu L, Mauri A, Paleari V, Rossi C, Venegoni M.
Unit of Biostatistics and Epidemiology, Department of Statistics, University of Milan-Bicocca, Milan, Italy.
Current use of fluoroquinolones significantly increased the risk of tendon disorders as a whole (odds ratio [OR] = 1.7; 95% CI 1.4, 2.0), tendon rupture (OR = 1.3; 95% CI 1.0, 1.8) and rupture of the Achilles' tendon (OR = 4.1; 95% CI 1.8, 9.6).
*******************
Avoiding Achilles tendon ruptures in the elderly - Literature Monitor
Clinician Reviews, Oct, 2003 The odds ratios (ORs) for Achilles tendon rupture were 4.3, 2.4, and 1.4 for current exposure, recent exposure, and past exposure to quinolones, respectively, compared with nonexposure.
***************
A more recent retrospective study [43] reported results that were collected from an outpatient database in The Netherlands. In that study, 1841 patients who had received a fluoroquinolone were compared with 9406 patients who had received another class of antimicrobials (amoxicillin, trimethoprim, trimethoprim-sulfamethoxazole, or nitrofurantoin) to determine the association, incidence, and relative risk of using a fluoroquinolone and developing tendinopathies.
This resulted in incidences of 7.74 cases per 100,000 days for fluoroquinolones or a relative risk of 2.4. Ofloxacin was shown to have a relative risk of 4.9. These risks adjusted to 3.7 for all fluoroquinolones and 10.1 for ofloxacin when the incidence of Achilles tendinopathies was evaluated specifically.
****************
Pharm World Sci. 2001 Jun;23(3):89-92. Related Articles, Links

Fluoroquinolone use and the change in incidence of tendon ruptures in the Netherlands.
van der Linden PD, Nab HW, Simonian S, Stricker BH, Leufkens HG, Herings RM.
Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, The Netherlands. vanderLinden@mi.fgg.eur.nl
The absolute number of hospitalised tendon ruptures increased with 28%, from 768 in 1991 to 984 in 1996. If the total increase of hospitalised non-traumatic tendon ruptures would be attributable to the increase in fluoroquinolone use, this would mean that the risk of non traumatic tendon ruptures to fluoroquinolones would be more than 250 times the risk during non-use.
****************
Expert Opin Drug Saf. 2005 Mar;4(2):299-309. Related Articles, Links

Fluoroquinolones and tendon disorders.
Melhus A.
Lund University, Department of Medical Microbiology, Malmo University Hospital, S-205 02 Malmo, Sweden. asa.melhus@mikrobiol.mas.lu.se
Despite many published case reports and approximately 3500 cases reported to the World Health Organization Collaborating Centre for Drug Monitoring, little is known about the mechanisms behind this fluoroquinolone-specific toxicity.
*****************

DUTCH

Fluoroquinolones have been associated with tendon disorders, usually during the first month of treatment,1-5 but the epidemiological evidence is scanty. We did a nested case-control study among users of fluoroquinolones in a large UK general practice database to study the association with Achilles tendon disorders. Our results indicate that this adverse effect is relatively rare, with an overall excess risk of 3.2 cases per 1000 patient years.
********************

Between 1987-1997 the FDA recieved 93 reports of tendon rupture, 103 reports of tendiopathy and 17 reports of tenosynovitis. This data is excluded from Public Citizens petition as all adrs reported prior to 1997 reside on a totally different database.
*******************

42 reported tendinopathies in 2000 Finland
************************

130 reported tendon inflammation or rupture (England, France and Belgium, 1996)
*******************

921 reported tendon disorders France
340 reported tendonitis, 81 tendon ruptures 1996, WHO
***********************

100 reported tendinopathies 1985-1992 France
**********************

421 reported tendon disorders and 81 tendon ruptures 1999
Therapie 1996; 51: 419-420 Tendon disorders with fluoroquinolones 421 cases have been collected by the Centre de Pharmacovigilance, 340 of tendinitis and 81 cases of tendon rupture.
****************

Australia. The Adverse Drug Reactions Advisory Committee first reported tendinitis in association with fluoroquinolone antibiotics in 1997. The Committee has continued to monitor this adverse reaction, and has now received 60 reports of tendinitis, tensosynovitis and/or tendon rupture in association with these drugs.
60 reported tendonitis August 1999
Fluoroquinolones tendinitis update Australia
Tendinitis associated with Fluoroquinolone therapy
(Pharmaceuticals Newsletters Nos 7&8 July & August 1997)
Australia
ADRAC Bulletin, vol 18, No 3, August 1999
Tendinitis and tendon rupture with
fluoroquinolones
*****************

704 achilles tendinitis, 38 ruptures 1992-1998 Netherlands
42 spontaneous reports 1988-1998
Tendon disorders attributed to fluoroquinolones; a study on 42 spontaneous reports in the period 1988-1998
Van Der Linden et al (American College of Rheumatology; Arthritis Care and Research 45; 2001 pages 235-239) June 2001
*****************

1847 reported tendinopathies December 2001
Tabelle 7
Pharmacovigilance: Meldungen von Tendinopathien im Vergleich zu allen gemeldeten unerwünschten Arzneimittelwirkungen (UAW), Stand 17. Dezember 2001.
****************

U.S. ARMED FORCES

Spontaneous Ruptures of the Achilles Tendon, US Armed Forces, 1998-2001
Methods. The Defense Medical Surveillance System was searched to identify all incident ambulatory visits of active duty servicemembers with a primary diagnosis of non-traumatic rupture of the achilles tendon (ICD-9- CM code 727.67) and other tendon ruptures (ICD-9- CM codes 727.60-727.66, 727.68-727.69) between January 1998 and May 2001.
The most striking finding of this analysis is the sudden and significant increase in rates of achilles tendon ruptures beginning in calendar year 2000. The increase was manifested across all Services and in most demographic subgroups (table 1). Rates
of non-traumatic ruptures of several other tendons also increased during the period; and increases in ruptures of the rotator cuff were comparable to those of the achilles tendon.
(This sudden increase corresponded directly with the addition of levaquin to the formulary. Coincidence? I doubt it)
***********************

You had asked: "Rather than add a boxed warning which is sure to pick up media attention (even if no new data is presented to doctors or patients), the public would be better served by the FDA actually looking into adverse events." And I would have to respond that the FDA has been "studying" this for more than two and one half DECADES. (since 1982) What more is to be gained by further delay? If in twenty six years the physician STILL cannot get it through his or her thick head that this reaction is not "rare" but rather a common adverse reaction that requires careful monitoring of the patient what possible use is further study going to be?

We know the mechanism of action, we know that in most cases it leaves the patient severely injured, we know that the scripting abuse is shamefull, and last but not least we know that the FDA is grossly malfeasant when it comes to drug safety.

Nothing has changed in reality other than "circling" the warning that has been on the label since 1996. Only problem is that the patient is the only one paying any attention to it, and then only after blowing a tendon.

No Doctor, further investigation is not clearly warranted. The facts have been established a decade ago. Clear and precise warnings devoid of anything that would trivialize or minimize these reactions, including a black box for the CNS and PNS reactions is what is now required. As well as "Dear Doctor Letters" for the clueless physician who to this day has NO prior knowledge concerning something that has been reported since 1982.

I know I had told you I would leave you in peace, but your statement of 1 out of 100,000 was so grievously in error I was compelled to comment even further. Try anywhere from 1-10 out of a hundred if we were to use the above citations as a guide.

Perhaps 1 out of a 100,000 is being recognized or reported, but that has nothing to do with the reality of the actual risk. I believe it to be
.5% of those being treated with a fluoroquinolone, and this is being ridiculously conservative. 1 out of a 100,000? Please, your killing me here.

Try explaining this to a fourteen year old kid who blew out the ligaments in BOTH knees after being exposed to levaquin. The prognosis for full recovery is questionable. This injury was fully avoidable as the patient complained of severe knee pain and the physician DISMISSED IT out of hand being related to levaquin. He was given this drug TWICE (even after reporting severe knee pain) to treat a fingernail infection. Chances are he is forever crippled now. You can read the full case study on the research site.

Of course the manufacturers claim that there are NO reports of ligament damage in the pediatric population involving levaquin.

In yet another case we have a young girl who will spend the rest of her life in a wheelchair now. Her tendons have been repaired so many times now she is beyond surgical intervention. Given cipro for an ear ache a decade ago. Will never walk again.

These are not side effects but criminal in nature for the manufacturers know full well what their products can do. And yet we fail to see proper warnings. These people are not "rare". Their name is "LEGIONS". Physicians who have a clue is what is rare here.

John P Slone, PhD said...

To echo David's points, I will add that even the current Levaquin product insert indicates a rate of 0.1% to 0.9% for tendonitis and other tendon disorders.

Anonymous said...

Just a few more FACTS:

http://www.youtube.com/watch?v=_hN16B-ESds&NR=1

Anonymous said...

Why have black box warnings been added? because incidence levels of patients sustaining injury have been rising worldwide. Bare in mind that the true numbers are not known because physicians are not recognizing what patients are reporting. Although these issues have been documented since the 80s’ emerging concerns with newer quinolones such as Levaquin have been documented...
Ministry of Health France 2001 issued Dear Doctor letters regarding Levaquin.
Ministry of Italy 2002 issued Dear Doctor letters regarding Levaquin.
No.14 The Pharmacovigilance Unit, Irish Medicines Board,Earlsford Centre, Earlsford Terrace, Dublin2 " Levofloxacin (Tavanic) " The Company responsible for marketing the above product in Ireland have agreed to undertake an epidemiological study to further investigate the risks associated with development of tendon disorders."
Switzerland
Schweizerische Ärztezeitung / Bulletin des médecins suisses / Bollettino dei medici svizzeri •2003;84: Nr 1/2 29 Editores Medicorum Helveticorum Fluoroquinolone und Tendinopathien: B. Schnyder, P. Caduff Einleitung
Safety Newsletters issued by World health Organization regarding Levaquin warnings.

Can you tell me how many other classes of antibiotics have had five drugs in its class removed off the market due to safety issues in as short a time and are associated with systemic tendon injuries ?

---This case study illustrates why black box warnings are important.
Patient admitted for surgery for abdominal abscess.
Oral levofloxacin, 500 mg/day, was initiated 5 days before admission. After surgery, the patient received 500 mg of intravenous levofloxacin daily with cefazolin for 5 days and then was continued on daily oral levofloxacin at the same dosage for an additional 5 days.
Discomfort in the left ankle was noted 2 days after the initial dose of levofloxacin and progressed throughout the peri- and post-operative period. One week after discharge, he presented to the emergency department with mild, nonpitting edema of the left calf and ankle, and pain on plantar flexion The patient was diagnosed with a muscle strain. Two weeks later, he was re-evaluated in the ER because of severe left leg pain, increased edema, erythema, and warmth extending to the knee, with tenderness on palpation of the Achilles tendon. the patient was admitted for a presumed cellulites. However, he continued to complain of ankle pain on weight bearing.
Later (MRI) confirmed a 2-cm segment of partial tearing of the Achilles tendon.

Had his doctors made the correlation on day 2 and stopped Levaquin this patient may have been spared such an outcome. Even after the fact the patient may have been spared rupture had the Medical community initiated proper intervention. If they can’t even corrrelate tendon issues on labeling since 1996, how can they grasp the many patients that sustain peripheral neuropathy, myalgias, arthralgias and cns reactions that they are oblivious to that can’t be identified on routine testing.

Anonymous said...

It was in disbelief that I read your opinions regarding the black box warnings on these drugs. I am amazed that a trained medical professional can attempt to argue that these are safe drugs yet at the same time acknowledge that the side effects do exist and are under reported. If the side effects exist and are much higher don’t you believe that the consumer might have a right to know that? Of course they don’t need to know! I mean it will just confuse the poor ignorant non-physicians out there and cause hysteria. And obviously a majority of the medical community shares your attitude because they just say - as you did - that all medication have side effects so we just have to deal with it. Well, I for one have seen the damage these drugs can cause. In my family, I have had two grandparents who had tendon ruptures from fq antibiotics - though the doctors denied any correlation between the meds and the tendon rupture- and many years later I have had terrible ongoing adrs from 4 days of ciproflaxin for a sinus infection. In fact I went from a healthy 37 year old with no muscle/tendon problems to feeling like an old man whose joints creak and pop like I was thirty years older within 4 days, and by the way that is just the muscle/tendon problems, didn’t mention the other adrs that are rare according to the pharmaceutical company. And yes I did call my doctor when I started having issues from the meds and was told - (Come on doctor you already know what I’m going to say right?) - it wasn’t from the cipro and to keep taking it for that infection so the bacteria wouldn’t become resistant. Of course the manufacturer warning said to take anyone off the cipro once they complained of burning, etc. in tendons but my doctor just didnt know or care about that. So maybe the black box warning really isn’t for the consumers at all. Maybe its for the ignorant people in the medical community who don’t know or just don’t care about whether these drugs cause tendon ruptures. And perhaps if the medical community would stop being pawns for pharmaceutical companies then you guys could start doing your job which is to help people, not just prescribe drugs that make certain companies stocks keep going higher.

deathbycipro said...

Dr. Mintz,
Imagine this... you take Cipro as prescribed by your physician. You trust your physician. You are one of the "rare ones" who develops about a dozen severe adverse reactions, all listed on the Cipro label. Psychlogical, neurological, and physical. The adverse reactions are permanent (mine date from 2006). You end up visiting about two dozen physicians and psychiatrists, thousands of dollars of tests, all of whom deny the Cipro could have caused it, and all of whom cannot offer any prescription, diet, therapy or what ever to improve your condition. I survived cancer at an early age in my teens, went through radiation and chemotherapy and believe me, I would rather go through that stuff again, than have suffered through the adverse reactions I have to this day from Cipro, in addition to the abuse from physicians who won't even take the time to match my symptoms with the ADR's.
I have great medical care - just no food, medicine or whatever can make me well. Now I'm just a statistic.

P.S. How many news stories edited out the line from the FDA advisory that says Cipro can cause chronic depression? Even the media edits what the public sees.

GC said...

The problem with fluoroquinolones, as has already been stated, is that the data are not accurate representations. The FDA Medwatch database is a very poor attempt at filing and categorizing adverse drug events; many times the adverse events are categorized incorrectly and misspellings and/or differentiation in drug name has lead to confusion and underreporting.

I am a biological scientist who has suffered horrendous damage (tendon, liver, musculoskeletal, heart, etc) due to Levaquin and I have personally gone through all of the clinical trials and read almost every scientific article on the subject, and the numbers being presented in the United States are suspect. Not to mention that a majority of the literature in the U.S. is being written by individuals directly affiliated with Ortho-McNeil or Johnson & Johnson. Germany, France, the UK, and the Netherlands are reporting a much higher incidence of tendon disorders and other serious ADRs directly attributable to fluoroquinolones. It is foolish to be stubbornly adamant about reliance on data when that data in itself is seriously flawed. The pharmaceutical company that is manufacturing this drug is also responsible for conducting clinical research on its side effects in a non-blind study and deems it acceptable to discount or ignore side effects because they were unexpected. That is not science, and nothing that comes from such a pursuit will be valid or applicable. Of course the numbers for tendon-related events are going to be low when it is very difficult to report symptoms to the FDA, the information is misclassified, doctors are not being receptive to patient’s complaints and making the connection between pain and FQs, and there is often a delayed reaction before onset of symptoms.

These ADRs are not rare. After experiencing this and speaking out about it, I have encountered numerous acquaintances that have also been affected by this class of drugs; if the numbers were truly 1 in 100,000 this would be quite anomalous. It is not possible to merely discredit qualitative data just because it represents events that are not what one wants to see. I have never suffered an adverse effect from any other medication and now I am in constant pain on a daily basis, have been completely debilitated, and have lost everything at the very beginning of my career. These drugs do serious and lasting harm. People are not numbers or random statistics and their protection should matter more than making a profit or finding a one-fit-all medication for bacterial infections. The entire system is in need of an overhaul and only when that happens will there be change for the better.

I sincerely hope that you will reconsider your stance on this issue and will have second thoughts any time you are tempted to prescribe a fluoroquinolone for a patient, no matter the “approved” circumstance.

Steven L said...

I have to agree with some of the other folks that there is perhaps a lot more to this than meets the eye.

It wouldn't be the first time that normal suggested pratice turned out to be a huge mistake.

I for one had Ofloxin prescribed to me for something that never really required it (i agree with your points on that!) but HAD i known about the side effects through some more obvious warning i would have AT LEAST have know that there *could* have been caused by this and stopped. Instead i assumed it was something else and continued taking them and it has had a fairly serious effects on me since Nov '07 now.

I had never been ill in my 30 odd years so i was slightly ignorant to the ignorance within the medical community as to potential issues with these drugs. They are way over-prescribed as you say, but no-one is actually warned as to potential side-effects.

I don't believe the numbers either. I know the worlds largest technology company completely revised their bug tracking programme because they realized they were only capturing issues where people realized the connection and in fact the realy numbers were very much higher.

I will follow your blog so keep posting on this.

Anonymous said...

I am a healthy female, 56 years old. I recently took Cipro for 7 days while I was on methylprednisolone. I have noted some relation to the steroid usage and think taht it makes the risks much higher if combined.
I was diagnosed with 3 tears in my tendons in the rotaor cuff after I finished the medicines. I am still suffering from the tears in my tendons and may have to have surgery. I also had a frozen shoulder and have been getting massage therapy. I have had a cordisone shot as well but am concerned that it may add to the problem. Does anyone know how long this stays in your system and could affect your muscles and tendons???
I had a fall the week before I took the Cipro so I was alarmed that it flared up 2 weeks afterwards. Now I am concerned that it was the CIPRO all along and not the fall.
help me!
LALady

teri said...

I see no problem with increasing the visibility of drug side effects - whether by the FDA, Public Citizen, physicians, or patients. Many doctors forget that patients have a right to be informed about side effects, or are not informed of side effects well enough to have intelligent conversations about them with their patients. I had a conversation with my doctor about possible side effects of Levaquin before I took it, and my doctor never mentioned tendon disorders, and convinced me to take the Levaquin since it'd be no problem for me to switch to a different antibiotic if I did have side effects. Or so we both thought.
Luckily my mom came across a publication by Public Citizen that talked about tendon damage by fluoroquinolones when I was 7 days into my 14+day course of Levaquin. I'd been wondering why my achilles were so sore and my calves so rock hard. Four years later with continued tendon and nerve pain, I'm still regretting that initial assumption that side effects go away when I quit ingesting the pills. But if this is what the result of 7 days of Levaquin is like, thank goodness for that article by Public Citizen that kept me from taking 14 days worth of pills.
I am a formerly healthy, active 35 year old (31 when I took Levaquin).

Steve said...

I'm sorry to hear about you guys suffering. This is the first time I've ever heard about antibiotics doing things like this.

What treatment did you guys get for the tendon problems? Was it painful enough that you had to also be prescribed pain killers? Did you go on SSI because of it?

Steve said...

Hi Dr. Mintz. Do you see any discussions about Cipro taking place on Sermo? Would you be curious about posing a question there regarding other MDs experiences with it?

david fuller said...

Steve, I have talked to tens of thousands of patients over the past eight years and the overwhelming majority of them stated first, that their physicians FLAT OUT DENIED that their tendon problems had anything to do with the fluoroquinolones, and secondly they were treated with steroids which only made matters far worse.

Any number of these patients have been disabled for life, lost thier lives savings, livelyhood, marriages, and even thier homes. They cannot get the medical care that they now need for the medical community refuses to associate thier problems with these drugs. They are subject to hundreds of test which for the most part come back normal. Shuttled from one doctor to another and they are being told that it is 'all in their heads' or 'anxiety' and given a psychiatric referral. Could not POSSIBLY be the drug.

This is a debilating injury that last for years and requires the use of potent narcotic pain killers. Not all patients rupture, which could possibly be repaired by surgery. They develope chronic and debilating tendonitis that does not respond to any treatment. They end up in wheelchairs, walkers or crutches instead.
There has even been reports of joint replacement being required as well.

Available treatments? I would love to hear of one. I have found no relief in the past eight years other than managing the pain as best I can. It has been unrelenting since August of 2000.

Steve said...

Why would there be a refusal to associate the problems with Cipro? Problems with the tendons is listed as an adverse effect.

If there is a problem with the tendons, then it should show up. They can't just say that it is "all in your head". It's not the same kind of experience where, for example, someone gets akathisia and they are unable to show any objective evidence of actually having akathisia.

I have recently taken Cipro and I don't feel like getting another chronic illness, I already have the tardive form of akathisia which has lasted for more than 4 years now. On the bright side of things, I seriously doubt anything can match what I already have and have gone through.

Steve said...

Also to be honest, reading all of this stuff and other things on the Internet have scared the living s*** out of me. That's all this reading of mine has really accomplished now. At the moment, I don't feel good, and I have no idea whether it has to do with the stupid Cipro or because I am nervous as hell.

Anonymous said...

I had a wonderful life until I took levaquin. I was healthy and happy and now I have tendonitis,heart problems, tinnitus, memory problems, eye and ear problems, psychotic episodes,etc. It ruined my life. I'm not the same person I used to be. Alll this after a 10 day course of levaquin.

FQ You said...

While I suppose that it is tempting to cling to the naïve belief that all pharmaceutical manufacturers truly have the patient’s best interest in mind and are in the service of advancing the sacrosanct “Western medicine;” that illusion clearly crumbles when examining the fluoroquinolones. The assertion that fluoroquinolones are relatively safe or well-tolerated is based on the industry-funded clinical trials and journal articles that employ some of the most obviously flawed analytical techniques I’ve ever seen. Why is it that nearly every European published article that addresses the safety of fluorquinolones recognizes serious cause for alarm, and yet American (i.e. industry-funded) studies almost invariably find these drugs to be safe enough for babies…(just kidding, the pediatric trials are underway now and haven’t been approved just yet). Cipro is a second-generation fluoroquinolone, of which 38% have been recalled from the market for serious safety issues. Levaquin is a third-generation FQ, of which 63% have been recalled from the market for safety issues (including that nagging side-effect of death). 71% of the fourth-generation FQ’s have been recalled to date and it would be a safe bet to forecast that going higher.

There’s quite a bit of a snow-job going on here as well. The medical industry and pharmaceutical companies affected love to keep the warning and subsequent discussion strictly isolated to tendon rupture. They’re quite happy for you not to know about QT elongation, hepatoxicity, Stevens-Johnson syndrome, severe dermatologic reactions, myalgia, arthralgia, or any one of the many side effects that are listed as warnings on the patient information (but only after being amended due to so many patient complaints). Furthermore, the notion that “tendon rupture” is by itself a symptom, as opposed to being a manifestation of a systemic attack perpetrated by these drugs against the body’s soft tissue, is a logical fallacy of the highest degree. Why is there a correlation between tendon rupture and fluoroquinolones? Because FQ’s weaken tendons to the point that the tendons are more prone to rupture (and this has been clearly demonstrated by studies of human tendon cells exposed to FQ’s in vitro). Thus, just because a tendon has not ruptured, it does not mean that systemic damage has not occurred. Has the tread of your car tires not worn at all unless it blows out? I have witnessed first-hand the complete logical failure of a doctor who didn’t understand this concept and it amazes me that someone could make it through medical school and be so incapable of undertaking the simple logical operation it requires to understand that there is a mechanism of damage to tendon tissue that may be a real problem even without tendon rupture.

But remember people, trust whatever your doctor tells you, particularly when it involves drug safety…doctor’s mistakes and drug side-effects are only the third most common cause of death in the USA.

Shelley Sealover said...

AVELOX/LEVAQUIN 20 pills, 2003 drastically altered my life.
I went from HEALTHY and ACTIVE mom of twin boys....to wondering if I was going to end up in a wheel chair. WHYYY???? I wasn't aware of the ADR's of these drugs. Didn't my doctor know??? WHYYY did I have to continually CHANGE DOCTORS for 3 years, because of their IGNORANCE??!! WHY am I STILL not able to get ONE DOCTOR to listen to me??? I've had TWO sets of X-Rays done on my hands and feet, by TWO different doctors...my x-rays are normal, why won't they order an MRI????
I already have tendinitis in both elbows. My feet, ankles, knees, shoulders, neck, both hands, fingers....all this and heart-palpitations, ringing in the ears, vibrations throughout my body, trigeminal neuralgia, stabbing pain in my head, tender areas over my head and enlarged lymph node behind my ear, swelling and redness, terrible anxiety with bouts of depression....all this from an antibiotic!! Not to mention the emotional trauma just dealing w/ the doctors!! Don't they read the PDR?? OR ARE THEY LYING and COVERING UP THE TRUTH??!! I've actually had one neurologist say "I don't know what that is" and "There's nothing I can do for you". WTF Well, at least he was honest huh??!! What is happening with this class of antibiotic is apalling...
a disgrace to the medical profession and all of humanity. Our lives were destroyed, and we'll never be the same.

http://blog.garymoller.com/2008/03/my-doctor-has-poisoned-me-with.html

~Shells~

Steve said...

So I took one 250mg dose of Ciprofloxacin, and then I felt like reading about it and I stumbled upon all of this mess of information.

What am I supposed to do now for the next year or so? Feel disabled by the fear you guys have put into me that I could get something debilitating suddenly? That kind of fear can also be very disabling, just like the disabling symptoms you guys talk about. You guys might think you are only helping by talking the way you do, but you are also hurting people by driving too much fear into them.

Dr. Matthew Mintz said...

There have been muliple commentor to this post relating problems with quinolones, so in fact it may be possible that rates are higher then even Public Citizen is suggesting. My original post was not intended to champion quinolones, but rather to be critical of the FDA regarding its recent decisions and how this comes out in the media.
1. There have been muliple comments about caridac, neurologic, and even psychiatric problems. Even if true, this is not what Public Citizen or the FDA was concerned about.
2. Dr. Fuller, I appreciate all the information you have posted. Since you are writing a book on this subject, you clearly know much more about the literature reported regarding Cipro then I do. Even if my rate of 4/100,000 is incorrect (I am quoted other data not my own research), I am not sure that your figure of 0.5% or 1/200 which you say is conservative sounds very realistic given the millions of prescriptions written.
3. There is no questions that patients and physicians need to be informed, and doctors should discuss risks and side effects with patients. However, this is true regardless of whether the effect is in a boxed warning or listed as a regular adverse event.

My issue is not so much with the safety of Cipro or not, but why the boxed warning now? Is there some new data that the FDA was not previously aware of? They state they had "conducted a new analysis" but we are provided no information of this analysis. What is the actual rate of tendonitis or tendon rupture? How conclusive is there investigation that this is indeed related to quinolones. If these drugs are truly dangerous and there is data to support that claim, then as a practicing physician, I would really like to know.
The problem is that what is reported in the media is that a drug is dangerous without the necessary data to back it up nor the guidance of in what situations use of the drug should be considered or avoided.
I will soon post about the general problems of boxed warnings and FDA announcements.

Dr. Matthew Mintz said...

Steve also had a good suggestion about posting this to Sermo, and I will follow through with this idea and let you know the results.

Steve said...

Thanks Dr., I thought it would be a good idea.

I was talking to my sister who knows a lot about alternative medicine. I was asking her about the tendon issues with Cipro, and she mentioned something called cissus quadrangularis. It might help problems with joints and tendons. I honestly haven't read much about it yet but I was figuring that if it's safe to take, then I suppose people could try it and see if it does anything.

Anonymous said...

Curious. Physicians have only experience and knowledge to guide them. I am a physician with an undifferentiated connective tissue disease treated with Hydroxychoroquine and Celebrex for almost two decades with joint and ligament pain. In the past two years I developed vocal cord atrophy. Just curious because no one has any clue why vocal cord atrophy occurred. Until there is repetition of symptoms, or an epidemiologic study, we physicians depend on Cochrane, NLM, and experience.

I also have a daughter treated with Atrabrine - Quinacrine - who developed transient full blown psychosis 25 years ago, a cause-effect association made not by doctors but by her mother who found a sentence in Goodman and Gilman to start her study. I was oblivious and doubtful at the time. Now there are reports of Quinolone antibiotic induced psychosis.

Doctors have to keep healthy respect for all meds, an ear and eye open for strange occurrences, and patients need to accept the best judgments of good physicians.

perlgrau said...

"My issue is not so much with the safety of Cipro or not, but why the boxed warning now? Is there some new data that the FDA was not previously aware of? They state they had "conducted a new analysis" but we are provided no information of this analysis."

The answer is simple... because the number of people being injured by this class of drugs can no longer be ignored. The pharmaceutical companies have attempted to cover this up for as long as possible and now with floods of people reporting their side effects, tendon-related or not, it can not be denied that FQs are bad news. European doctors have known this for a long time; there is literature out there that attests to the fact that FQs cause tenocyte apoptosis. Why are U.S. doctors so ignorant about drugs that they so commonly prescribe?

Steve said...

I felt like calling a pharmacist at the Walgreens I go to. I asked about Cipro and she said that she sees it get prescribed a lot, and that she can't remember anyone calling there about having really bad side effects with it. Also, she said she took it a few times and never got anything from it either.

I was just curious.

david fuller said...

Steve has raised a valid issue here and I would hope that others who have been commenting on Dr. Mintz’s site would not abuse his hospitality by attacking this individual.

He questioned the wisdom of these post and how they have “crippled” him mentally with fear.

The first question that comes to mind is why is he only now being made aware of these risks? The logical answer is one of two things. The first being that his physician had no prior knowledge that he or she was putting this patient at risk of being crippled for life and failed to disclose this risk as they knew nothing about it. Which of course adds considerable weight to the arguments being presented here that the warnings are grossly inadequate.

The second answer being that the physician felt that his or her patient was not intelligent or sophisticated enough to actively participate in his own care.

Either way Steve’s angst should be directed towards those who have failed to engage in a full and complete risk/benefit discussion prior to prescribing this line of treatment. Not those who have posted here in a sincere effort to prevent what Steve now faces from being repeated in others.

It is both the moral and legal obligation of the treating physician to engage in a reasonable risk/benefit discussion with the patient prior to recommending a course of treatment. The risk of permanent injury is of such a nature it cannot be excluded from such a discussion. Not each and every possible adverse reaction needs to be discussed, but those of a permanent nature cannot be dismissed.

It is also the patient’s obligation to ask questions and to do at least a bit of research concerning what is being proposed. As well as to READ the information that accompanies the drug. If for no other reason than to be informed enough to ask relevant questions.

But I hold both the physicians and the patients harmless when they have been lied to by the drug manufacturers. They cannot act as learned intermentaries when they are being misled and lied to about the true risk of any drug. Nor can the patient be educated when all the true facts are hidden from them.

Steve, we are not to blame for your fear. Your physicians failed you when they did not reveal this information BEFORE you took the drug. I suggest you return to your physician and confront him or her with this information and see if there is a safer alternative other than the fluoroquinolones to treat whatever ails you. I am willing to bet that there is.

On a side note to Dr. Mintz, I am NOT a physician. Nor am I in any way a part of the medical community. I am a researcher whose life was destroyed by these drugs on August 21, 2000, who has been seeking a cure for the medical mess that I have become. If you would write to me via my private email address I would be more than willing to provide you with the copies of the citations upon which I am basing this risk factor. These are published citations taken from the leading medical journals.

david fuller said...

"My issue is not so much with the safety of Cipro or not, but why the boxed warning now? "

I hate to be such a nuisance here Dr. Mintz, but you keep asking questions that I believe I can answer.

The reason we are seeing these additional warning now is for the simple fact that the FDA stands a very good chance, based upon the caselaw I have reviewed, of losing in Federal Court. When, not if, this takes place the Judge will no doubt demand a full disclosure of the true safety profile of this class. Which of course would be devastating as not a doctor worth a salt would then be able to prescribe this class with a clear conscience.

There is NO new data being reviewed by the FDA. In fact they have DELIBERATELY excluded all the reports from 1982-1996. Fourteen years worth, as this information resides on a totally different database than the one currently being utilized by medwatch.

All this is is nothing more than legal maneuvering by the FDA, on behalf of the drug manufacturers, to once again hide this safety profile. Hoping that this frivolous addition would be sufficient for the Judge to dismiss the case filed by Public Citizen.

The Attorney General of the State of Illinois has stated that this is grossly insufficient and they will continue in their efforts for full disclosure. Which will be vigorously opposed by the FDA. I am willing to bet the farm on this. I have bet the 'farm' more times than you could imagine over the years and I am still living on it.

EVERYTHING you find on the research site has been forwarded to the FDA years ago. For more than a decade now thier response to me has been "we are continuing to study the issues you have raised and have not yet reach a decision..."

Public Citizen is why they are now adding these warnings. It has NOTHING to do with the risk to the patient and there is NO new data that they are relying upon.

Shelley Sealover said...

Steve said...
"I felt like calling a pharmacist at the Walgreens I go to. I asked about Cipro and she said that she sees it get prescribed a lot, and that she can't remember anyone calling there about having really bad side effects with it. Also, she said she took it a few times and never got anything from it either."

Steve,
I did that too, in the beginning, after suffering 2 yrs severe adverse reactions from Avelox and Levaquin (20 pills total, prescribed for sinus). One pharmacist said, very sternly, I might add, "It's a good antibiotic". Good, meaning it will kill anything in it's path??
I proceeded to enlighten him about the ADR's while showing him my swelled and sore hands. With that he said "Side-effects are very rare". Gee, I wonder where he heard that before. [sarcasm]
A different pharmacist (Doc Marc) at the very same pharmacy (Drug City)actually looked at me and listened to what I had to say. Nodding his head in agreement, he even asked questions. But he wasn't able to offer anything promising as far as treatment advice. So depending on who you ask, you will get varied opinions. And opinions aren't worth much. Best to just listen to the voice of experience, facts and evidence. As for patients calling the pharmacy to complain, well, one pharmacist wouldn't be aware of every call concerning every drug. If a patient had a problem w/ the medication, he would probably be more likely to contact his doctor. My doctor had also told me he took Cipro himself. First: I don't believe him. He would have to prove that one to me. And secondly: these FQ's are cumulative...and the debilitating reaction may be delayed, as was my case. I would also like to add, many patients are being misdiagnosed by their doctors...with conditions such as fibromyalgia, chronic fatigue or some mysterious illness (like my boys' elementary school music teacher who was out sick for months due to a "violent reaction to Cipro"...and no, not one of his doctors recognized it....but I did!) I personally have heard many stories of people who've been diagnosed w/ fibro, and after discussing the FQ's w/ them, guess what, turns out they've taken Cipro...or Levaquin. Or both.
So many people whom I've personally spoken to....suffering, not knowing why.
Until one day, all the peices fit!! I get emails every day.....same story. One more thing....as for being "scared", you can bet your life on it, that every single one of us who has ever ingested an FQ wishes he/she was lucky enough to have had the beejeebies scared out of him....and NEVER put this poison into our bodies. If I've scared you, I know I've done a good thing.

~Shells~
DEADLY LEVAQUIN/AVELOX
only 20 pills

Steve said...

I am guessing that most people don't look up information on Cipro before taking it. Only afterwards, for whatever reason, do they. And it's worse to be scared after you've taken it than before you have taken it.

I don't believe scaring someone after they have taken it is really a good thing, they could get a great deal of anxiety and then have difficulty discerning whether their symptoms are being caused psycho-somatically by the anxiety or whether the symptoms are being caused by Cipro, or maybe being caused by something else.

It can be useful still though to tell people your stories. Because if someone reading your stories does develop symptoms, and they did take Cipro, then they at least know what possibly is causing the symptoms. Especially if the symptom is something like tendon rupture, which is a very objective thing and obviously wouldn't be caused by anxiety.

Dr. Matthew Mintz said...

David,
One thing (and there is probably much more) that we can agree on is that full disclosure is good for everyone. If the FDA has been hiding safety data for years, this data should come to light. The box warning, with no clear rationale-not saying there isn't a reason, just that the reason for heightening the warning wasn't made very clear to the public-makes it difficult for clinicians to make a medical decision. Is the warning so serious that we should virtually never use these products or is this just something that physicians should be more aware of so the drug isn't given out as if there are no safety issues? Without actual data, based on the warning and the info on the FDA site, it's hard to make a judegement. Based on your posts and post by others experiencing severe consequences from fluoroquinolones, it appears there may be more to the story.

shelley sealover said...

Steve said...

"And it's worse to be scared after you've taken it than before you have taken it."

Thanks for pointing that out to me. I should have remembered, especially since I've experienced much of the same. For me the fear had to take a back seat to courage and strength. The damage was already done.

~Shells~

david fuller said...

“Without actual data, based on the warning and the info on the FDA site, it's hard to make a judegement.”(sic)

Kinda puts the physician between a rock and hard place doesn’t it? First, this is the most current data that I am aware of that the FDA has failed to share with the medical community:

The latest numbers in regards to tendon ruptures found on the FDA’s database (1996-2008)

Cipro =648 ruptures
Levaquin =532 ruptures

This does not include the rest of the drugs found within this class or the different spellings used, or the different names used anywhere other than the United States. Nor does it include all various ways in which the FDA codes such a reaction, and there are literally dozens of different terms used by the FDA to describe the very same event.

The 2007 numbers from the FDA regarding other adrs associated with this class:

Levaquin Nov. 1997 - May 30, 2007
Total reactions: 39,128
Total death outcomes by case: 806
Total individual safety reports: 9,711

Floxin: Nov. 1997 - May 30, 2007
Total reactions: 13,495
Total death outcomes by case: 311
Total individual safety reports: 2,962

Cipro: Nov. 1997 - May 30, 2007
Total reactions: 40,395
Total death outcomes by case: 837
Total individual safety reports: 8,766

Proquin (ciprofloxacin) Nov. 1, 1997 - June 5, 2007
Total reactions: 40,151
Total death outcomes by case: 831
Total individual safety reports: 8,688

Tequin: Nov. 1997 - June 5, 2007
Total reactions: 15,494
Total death outcomes by case: 196
Total individual safety reports: 5,307

Factive: Nov. 1997 - June 5, 2007
Total reactions: 1,979
Total death outcomes by case: 7
Total individual safety reports: 1,108

Avelox: Nov. 1997 - June 5, 2007
Total reactions: 30,160
Total death outcomes by case: 337
Total individual safety reports: 7,391

Other considerations:

“Severe, and sometimes fatal, cases of hepatotoxicity have been reported post-marketing in
association with LEVAQUIN®. The majority of fatal hepatotoxicity reports occurred in
patients 65 years of age or older and most were not associated with hypersensitivity.
LEVAQUIN® should be discontinued immediately if the patient develops signs and symptoms
of hepatitis… Hepatotoxicity: Severe hepatotoxicity (including acute hepatitis and fatal events) has been
reported in patients taking LEVAQUIN®. Patients should inform their physician and be
instructed to discontinue LEVAQUIN® treatment immediately if they experience any signs
or symptoms of liver injury including: loss of appetite, nausea, vomiting, fever, weakness,
tiredness, right upper quadrant tenderness, itching, yellowing of the skin and eyes, light
colored bowel movements or dark colored urine.” (11-9-2007) (sic) Renata Albrecht, M.D. Director
Division of Special Pathogen and Transplant Products / Office of Antimicrobial Products Center for Drug Evaluation and Research (The same FDA doctor being quoted in the media regarding the tendon issue)

The following is stated within the European “Dear Doctor Letter” (Feb 2008) issued by Bayer that was NEVER
issued here in the States:

“Treatment with moxifloxacin is associated with a risk of developing fulminant hepatitis potentially leading to life threatening liver failure and risk of potentially life threatening bullous skin reactions like Stevens-Johnson-Syndrome (SJS) or toxic epidermal necrolysis (TEN).” (sic)

“The liver injuries possibly related to moxifloxacin were more frequently of cholestatic or mixed
hepatocellular-cholestatic than of hepatocellular type. Onset of symptoms was usually between 3 and 10 days.
Isolated cases of delayed hepatotoxic effects were also identified and usually occurred 5 to 30 days after
cessation of moxifloxacin therapy. Eight reports of fatal hepatic injuries were considered as possibly related to moxifloxacin therapy. Cases of positive re-challenge gave further evidence of a causal relationship.”(sic)

“TEN was reported in several cases where a causal relationship was considered possible; this included two
cases with fatal outcome. Additionally, a total of 35 individual cases of SJS were reported, including three
cases where there was a fatal outcome and seven cases which were considered life-threatening. In these 10
cases of severe SJS, a progression to TEN was documented in three patients. Based on the large patient
exposure, the incidence of both life threatening liver injuries and TEN is very low, although a definite
frequency cannot be calculated from these reports.”(sic)

Recent Pediatric studies concerning levaquin:

1st Study: Of the 712 subjects evaluable for safety, 275 (52%) levofloxacin-treated subjects experienced 1
or more adverse event. Seventeen subjects had 23 adverse events of marked severity. Twenty-three subjects experienced MS adverse events. Serious adverse events were reported in 33 (6%) levofloxacin-treated subjects. Two serious adverse events in levofloxacin-treated subjects resulted in fatal outcomes. Adverse events leading
to treatment discontinuation occurred in 12 (2%).

2nd Study: Of the 204 subjects evaluable for safety, 122 experienced 1 or more adverse events. Twelve were
marked in severity: Twelve subjects (6%) discontinued study drug due to an adverse event. Six subjects experienced a MS adverse event. There were no deaths. Seven subjects (3%) experienced 8 serious adverse
events.

3rd Study: Results of this study are not available even though they are required to be posted on the clinicaltrials.gov website within one year of completion. There is no conclusions posted on that site as of
3-26-2008

4th Study: Results of this study will not be available for about 15-20 years. Patients who develop one or more musculoskeletal disorders during the first year will be monitored until they have completed puberty
(15th birthday for females and 17th birthday for males).

5th Study: Results of this study are not available even though they are required to be posted on the
clinicaltrials.gov website within one year of completion. There is not conclusions posted on that site as
of 3-26-2008. The results of this study have not been posted on clinicaltrials.gov as required by law.
No results available to be posted as none can be found at this time, even though Federal Law requires that
they be available through the clinicaltrials.gov website a through search failed to locate this study and the
results thereto.

So based upon this continuing effort to mislead the physicians by the FDA, I would think you are on your own. Before commenting further, I would like to make known that I DO NOT advocate the complete removal of this class. Rather I advocate the patient being fully informed of the inherent risk, which I believe to be the absolute right of the patient, as well as a full and complete risk/benefit discussion taking place prior to therapy. Together with rational and justifiable use, not the wanton scripting abuse that takes place today.

It is appalling that in one hospital Ciprofloxacin is jokingly referred to as ‘vitamin C’, as every patient gets a dose there, whether needed or not. And in one study of the use of the fluoroquinolone class within the emergency room at a hospital it was found that in ONLY 1% of the cases studied did the patient receive a fluoroquinolone drug in the correct dose for the correct indication. The other 99% of the time it’s use or doseage was not justified.

As such may I be so bold and risk your displeasure to suggest the following ‘guidelines’?:

The first question that needs to be asked is whether or not the medical condition of the patient is such that the risk of crippling or even killing the patient is warranted. Is the bacterial infection of such a nature that the use of the fluoroquinolone is mandated or the patient will be at risk of losing life or limb? If the answer is “YES” then this is a ‘no brainer’.

You prescribe the drug and then retire to the chapel to pray with the family that it works. Sometimes there is no luxury of debate or even time to enter into a risk/benefit discussion with the patient. In those situations you hid hard and you hit fast with the most potent and toxic drug in your arsenal. Which currently is a fluoroquinone drug.

If the answer to the first question is “NO” then the second question becomes what DO I have available that is safer and will result in the eradication of the infection? Perhaps it may take a bit longer and perhaps the patient will be uncomfortable for an additional length of time. But what is in the best interest of the patient? This then becomes the drug of choice rather than a fluoroquinolone. Yet again another ‘no brainer’.

But far too often the treating physician has become complacent and perhaps even lazy and prescribes out of habit rather than need. And when the patient presents with side effects they are labeled difficult patients or even hypochondriacs. Best to just give them the biggest gun available to make them go away.

Statistics are meaningless. You give me the raw data and any skilled statatisian will manipulate it to support any forgone conclusion you care to reach. Whether the risk factor that you are seeking guidance on is one in ten or one in a million is irrelevant.

You have absolutely no way to determine if the patient setting in front of you will be that ONE. So why not be on the safe side and assume that he or she is and act accordingly? It makes no difference to the patient that they are to be considered “rare”. That does nothing but put a label on their misery and does nothing to improve the odds they face.

You toss the dice every time you prescribe a drug. Is it not enough to know that the fluoroquinolones have a history of turning up ‘craps’ and disabling the patient, where as other drugs that are just as effective may not?

So having taken fifteens minutes of your time with this discourse I would now ask you to lend me your hand to help this decrypted, crippled, blind old man off his soap box.

As I shuffle away I cannot help but see over my shoulder the masses of injured patients who have waited patiently for me to shut up so that they may have a chance to have their say. I cannot help but be haunted by the words of Ted Nealy, who has been portraying the leading role in Jesus Christ Superstar for near as long as I have been injured by these drugs, when he states that “There are far too many of you…” when approached by the sick and injured.

I feel the same every time I open an email from yet another victim of this never-ending scripting abuse. I too say….”There are far too many of you…” That in itself should be all the guidance you need to make the correct choice.

shelley sealover said...

david fuller said...

"As I shuffle away I cannot help but see over my shoulder the masses of injured patients who have waited patiently for me to shut up so that they may have a chance to have their say."

With that post (as well as many others) you have spoken for me.

I'm getting tired....
I cannot thank you enough.

~Shells~

Anonymous said...

I wonder if there might be a genetic predisposition among a small percentage of the population that puts them at risk of tendon rupture after fluoroquinolone exposure. I especially am curious about this because many of the commenters here have noted that symptoms occurred with just a few days of quinolone treatment.

I have cystic fibrosis and have taken Cipro without problems more times than I can count. For me the benefits definitely outweigh the risks; without Cipro I'd have to get IV antibiotics much more frequently. I'm also a physician and rarely prescribe it but will be even more careful now.

david fuller said...

"I wonder if there might be a genetic predisposition among a small percentage of the population that puts them at risk of tendon rupture after fluoroquinolone exposure."

I have been researching this for almost a decade now and have not read one study that would indicate this to be a factor. Not saying it is or is not, simply nothing to be found to date regarding such a theory.

We do know however that the cytochrome P450 pathway is involved in most drug metabolisms and Cipro inhibits the CYP1A2 as well as CYP3A4. Perhaps there is something genetically wrong here.

But this of course would fail to account for the direct toxicity found within the vitro studies that document the mechanism of action by which such ruptures take place.

I am pleased however that you have indicated that you will be more cautious regarding these drugs. Not everyone will suffer a severe side effect. And indeed I know of many a case where the patient states that they have taken them for years without a problem and all of a sudden all hell breaks loose. No obvious, or logical, reason for such phenomena.

Unfortunately in my case my first exposure to floxin back in the mid eighties resulted in a heart attack as well as damage to my heart valves. The second and third exposures to cipro in the nineties resulted in severe muscle and tendon problems and the loss of vision. The fourth exposure in 2000 (floxin, cipro and then levaquin at a 1000 mg a day) put me in ER, damn near killed me and crippled me for life.

There is not enough space in this comment box to list all the medical problems I have from these drugs. But they trashed my liver, kidneys, digestive system, heart, vision and hearing, as well as muscles and tendons. I am an irreparable medical mess.

The floxin in the eighties was for pneumonia, cipro in the nineties for a head cold and mild infection of the empydemitis (sp?) and the fourth exposure was for a kidney stone brought on by the third exposure to cipro which was combined with a medral dose pack. So one out of four was warranted where as the other three were not.

So perhaps there is even an accumulative effect as well as each exposure resulted in increasing severe damage to me. Just imagine the life I could have had if the doctors had realized back in the eighties that I had suffered an adverse reaction. Rather than the misery I have endured for two and one half decades now. Even back in 2000 I was told that these drug could not possibly be responsible by the treating physician, even though EVERYTHING I WAS EXPERIENCING has proven to be a listed, published and known adverse reaction to this class.

Again I bless you for being more cautious. Just imagine how many people that will prevent from suffering as I do every day of my life. And please don’t pity me, pity those who have no clue instead. They are far more deserving of that than I.

Ty Taylor said...

Before you comment on a story please do a little research. I was a healthy 42 year old who just had my 3rd tendon reattachment and waiting for this one to heal so I can go in for my 4th reattachment due to Levaquin. I also get the great benefits of Achilles tendinitis, joint pain and other great ADR's. Instead of listening to what the Pharm rep is whispering in your ear, I beg you to look at the clinical studies being done in other counties. The rates are much higher than what the FDA is reporting. Due to the so called "unnecessary fear provoked by Public Citizen and the media" it may keep a family member or friend from becoming a statistic.

Kim Bean said...

I am a 43-year-old woman. In December of 06, I was prescribed Levaquin and then Avelox. I took them for a total of 17 days. Within 24 hours, I felt like I was in a fog. Within two days, I was awakened from a sound sleep with severe muscle cramps in my thighs. My leg pain was excruciating. I was also experiencing electrical and burning sensations all over. I called my doctor. She didn't tell me to stop taking my antibiotic. I continued to take it, never attributing my pain to an antibiotic. Over the next 6 months, I developed tendonitis in every possible tendon in my body. As a professional pianist and piano teacher, I couldn’t practice the piano for 2 months. I couldn’t teach for a whole month as I could barely hobble around. I couldn't drive a car due to the pain in my calves, thighs and knees for 6 months. I couldn't walk 20 yards without my legs giving out. I couldn't even rest my foot on the floor for more than a minute because of the pressure on my tendons. I had to constantly keep changing my position from sitting, to standing, to lying down. I had muscle twitching all over and severe insomnia for about 5 months. I had terrible night sweats, but could never get warm during the day. I lost 13 pounds within 2 weeks. I spent over $3000.00 on medical tests to rule out everything from Celiac's disease to neuromuscular diseases and Sjogren's syndrome. Of course, you can imagine the anxiety over the thought of having a disease like ALS. Gradually, I began to get better. Nearly 2 years later, I have mostly healed. However, I do continue to get tendonitis if I am not careful. I workout daily, as this seems to help ease the arthritis I now have. However, I have to be very careful to not over do it. I have nerve pain in my shoulder and neck that isn't getting better. My husband, an MD, was ashamed that he didn't recognize the symptoms and stop me from taking the drug. He and I both just want doctors to inform patients and recognize these reactions. If I had only known within the first 24 hours to stop taking the drug, I probably wouldn't have had such a severe reaction.

Matthew said...

On my 23rd birthday I started ciproI only took 3 doses of cipro in total before realizing what was happening... I went from being a very healthy 23 year old male who was athletic for over 10 years doing Karate, Yoga, Football, Judo and other sports, I eat an extremely healthy diet, no bad foods at all, and generally take care of myself in everyway possible, I have never drank alcohol and never smoked... I have all the blood tests and other tests to prove how healthy I was. After taking the ciprofloxacin my life completely changed in an instant, for months I had to crawl around my house beacuse of the pain in my achilles tendons. I noticed the side effects approx two hours after taking cipro... however my doctor told me to carry on taking it! (I stopped myself after 3rd dose).


After my very first dose of cipro I had a cascade of symptoms that I never experienced in my life before such as; Bilateral Achilles tendinitis, Tendinitis in both wrists, Chronic insomnia where it would take 5 hours to fall to sleep then I would be waking up every 1 hour and this continued for 4 months. What is interesting is that I have never had insomnia in my life before cipro. I also experienced chronic nightmares, moderate peripheral neuropathy (burning, tingling, numbness), constant body tremors, dry eyes, dry mouth, dry skin, pulsating sensation in my stomach/neck/hands, pulsatile tinnitus, tinnitus (4 noises), muscle pains, joint pains. Eye flashes, blurry vision, eye floaters, static/snow vision, inability to adjust from light to dark (right eye), twitching, dizziness, stiff neck, head pressure, eye pain, ear pain, difficulty swallowing, aspiration, GERD, lack of appetite. I also had massive increase in spider veins, nail ridges, constant wrinkled fingers, nail growh abnormalities... and my skin become thinner around my body (breakdown of collagen?).


It has been 9 months now since I had my reaction and I still cannot function properly because of my tendinitis... about 80% of my symptoms have lessened or have now gone away. I am improving at a very slow and frustating rate. How can I go from being extremely healthy and having just a minor infection to not being able to function and feeling like I had aged 50 years in one night. I have lost thousands of pounds in earnings and have not been able to work consistently since my reaction.

I have seen literally thousands of people in the same position as me, a significant portion of them were healthy and young like me, and now are disabled. How can the true devestation of this class of antibiotics be revealed if things like tendon damage does not show for months after the last dose? I feel the numbers reported are probably very small because people are not associating antibiotic use with tendon problems, and other problems as I mentioned above. From the moment I took the antibiotic I had a cascade of symptoms that never stopped showing up until about 4 months post-cipro. From there I healed from most of it but now have several injuries which are likely to be with me for life, or until medicine can fix them. I just want my life back, and for doctor to prescribe quinolone drugs when only absolutely needed

Matthew said...

I have an idea that the reason why some people can take these quinolones in the past, then suddenly react to them is because of epigenetic changes (gene expression which can be changed by diet, weight, supplement usage, stressors, environment etc..)

Karen Fisher said...

I was a healthy 42 yr old mother of three with a doctorate that I worked very hard to get. After taking 4.5 days of cipro for a simple UTI, I couldnt work for almost 3 months and I lost my practice. I suffered tendinosis, very painful, head pressure, vasculitis, peripheral neuropathy, tachycardia, and countless other adverse affects.
It is 7 mos later and I am still suffering. There is no cure or treatment, just try to figure out a way to deal with the loss of function and ability to care for my children and to continue my career.
All this is robbed from me. I now have multiple tumors over my body which I did not have before. I dont know what my future is now. I could have had a wonderful life. Now I look through tear filled eyes all the time.

Rick said...

I have just read the discourse here and I would like to add my small voice to the call to provide FULL DISCLOSURE to patients regarding ADRs to fluoroquinolones.

Dr. Mintz: there is no new data that the FDA knows and you or we don't....the FDA has ignored all the data on the adverse effects of these deadly drugs for at least 25 years.

The thing is...the ADRs to this class of drugs can be permanent. If a person is lucky enough to recover... it's usually not a full recovery. I would not want to be given these drugs without an explanation of the risks...yet that is exactly what happened. I was given avelox for a sinus infection, and 3 years later I am not the same. I have permanent neuropathy, tinnitis, and short term memory loss. I'm quite sure the doctor didn't know the risks associated with FQs either.

This is nothing short of a health crisis in this country. Thousands upon thousands of people are being mis-diagnosed because nobody knows the ADR profile of this class of drugs. And the FDA is not forthcoming!

In my case, my ADRs didn't start until almost 3 months after stopping therapy. No wonder nobody could connect the cause to the effect.

rick said...

I should also say that nobody in the med. community is LOOKING for ADRs to drugs. It simply is not in anybody's diagnostic paradigm.

Dr. Mintz: Do you consider drugs as a cause for you patients' symptoms?

Anonymous said...

took 28 pills of 500 mg levaquin in July 2001. My life has not been the same since. The drug (as confirmed by several doctors including mayo clinic) caused tendon damage all over my body, extensive peripheral neuropathy, vision damage, hearing damage, insomnia, severe fatigue, night sweats, non stop 24/7 muscle twitching in several areas, muscle weakness and numerous other issues. I was a very athletic individual and active participant in the lives of my two young children. That all changed in July 2001. Seven years later, I have improved greatly, but it took 4.5 years to really see the healing begin. Even now, the tendons in my feet, knees and shoulders are still too damaged to allow me to play most of the sports I once loved including tennis, racquetball, running, baseball, etc.

Stay away from this drug unless it is the ONLY option to keep you from dying.

Anonymous said...

I took exactly 2500 mg (10 pills of 250 mg) of ciprofloxacin over a period of 5 days in the summer of 2007 .

Because of Cipro I need a wheelchair now.

I've always been a healthy person. I took part in squash, tennis, football and jogging.

After taking the third pill the first signs started. I had joint and muscles pain in my calves and arms. Because it was on saturday I did not call my doctor. I did read the paper in the box of Cipro and it did not say to stop immediately. If I did stop I would have less problems. Damned why don’t they warn us better.

On monday I went to my doctor and he said it was from Cipro but he thought it would not harm to go further. He did not know what to do.

MY SYMPTOMS IN ORDER OF APPEARANCE
Joint pains
Calves/Achilles Arms Hamstrings Shoulders
Muscle pains
Increased joint stiffness
Dry ears
Dry eyes
Dry mouth and nose
Insomnia
Numbness feeling right foot
Joint popping all over my body
Dry sinus
Ear pain
Red skin after touching it / pressure on it

It is almost a year after taking Cipro.

I cannot walk because of pain in calves and Achilles.
I need a wheelchair out of my home.

David said...

At age 46 I was given 750 mg of Levaquin for 21 days to combat epidytimitis in 2007. I had some
mild side effects during the course of treatment, ie... mild insomnia, mild joint aches, and some skin itching. After finishing my course of treatment I have developed more severe muscle and joint aches and pains
along with muscle weakness. Alot of my joints, especially my knees and wrists became very frail and prone to easy damage.
At a year out I have experienced Severe joint pain (especially of the knees and leg muscles), weakness in the
arms and neck, never-ending neck pain (constant muscle strains and pains), insomnia, anxiety, depression, dryness and vision issues with left eye, and various peripheral neuropathies. I have had periods of
no symptoms followed by strong relapses (cycles).Prior to this adverse drug reaction I was very healthy and bicycle 7-10 miles a day. I have never regained the ability to aerobic exercise and have to constantly guard against joint damage.

mwood said...

Unfortunately, without appropriate warnings, patients and doctors don't even recognize when a drug is causing dangerous issues. The first drugs I was given warned that caution should be used in the elderly due to tendon issues. That was years ago. I was not elderly, in my 30s. The recent dose of Cipro I took warned of tendon ruptures. I didn't have a rupture, just a severe cramp causing temporary disformity and resulting in pain, and my doctor said she didn't realize that all of the pain I'd been in for over a year was related to several doses of Levaquin she kept giving me. The warnings list the extremes, so those with ruptures will now know what happenend, but many others still won't know that this drug family has many many more side effects they may be suffering from. It can save lives, but everyone should be informed of all of their options.

Laurie Reylek said...

These drugs are all extremely dangerous and carry bigger risks than are being portrayed.I was a healthy, vibrant and active 27 year-old wife and mother when I was prescribed Cipro on September 25, 2007. I stopped after the third 500 MG pill after a "guardian angel" friend helped me connect the insomnia and severe headache I was experiencing to the Cipro....within 24 hours of discontinuing the Cipro symptoms intensified and multiplied. I experienced severe neuropathy all over my body, tachycardia, insomnia (not one minute of sleep for over two weeks), profuse sweating, inability to stop pacing, psychosis, loss of appetite, metallic taste in my mouth, mouth sores, dizziness, tendon pain, joint pain, extreme weakness in every muscle of my body especially my jaw, high blood sugar readings, inability to focus my vision on objects, eye floaters, and many more. After this acute stage subsided I have since gone on to develop vertigo (bad enough at times that turning over in bed induced vomiting), severe jaw pain, treatment-resistant hypothyroidism, inability to digest food and extreme stomach pain, atonic colon, skin that will not heal, multiple food and chemical sensitivities broken capillaries all over my body/face, weight loss, extreme fatigue, and a disabling skin reaction to any amount of UV light, and I look like a deflated balloon...there are more but my memory has been affected as well. If I had been given adequate risk/benefit warnings regarding taking this drug I would have absolutely opted to take another antibiotic instead. This drug has ruined my life, and robbed my children of their mother and my husband of his wife. There is not one aspect of my life that hasn't been affected by those three Cipro pills taken almost 10 months ago. My brief experience with conventional medicine is officially done....if there is one thing that I am grateful for from going through this experience it has taught me that without exception no pharmaceuticals can be trusted, and I will never put my life and health in the hands of conventional medicine again

Anonymous said...

The black box warning about tendon ruptures is a good start, but many more symptoms have to be included like damage to the liver, CNS system, heart… and it must be underlined that the symptoms do not only last during the treatment but that they can stay for a long time or even forever – in my case since 20 years and there is no end in sight. I only took 1 pill Floxin.

What shocks me is that the doctors, who describe these drugs, are not properly informed by the manufactures about the real toxicity and ADRs of the fluoroquinolones. In addition to this the medical class ignores, if a patient shows up with ADRs and is able to connect it directly with the treatment with this drug.

For me it was a battle every day, because it damaged the blood-brain-barrier, which protects the brain. Now substances can enter and cause big damage similar to stroke or brain tumor. I have the feeling that a mouse is eating up my brain bite by bite and it takes away slowly but steadily many of the normal skills and my personality. In order to protect my brain I have to isolate myself and I have to avoid all exposures.
Namid

LJ said...

Medical arrogance could be a dangerousl thing.

Flouroquinolones antibiotics (Levaquin, Cipro, Avelox) can be very dangerous. It’s imperative to understand the potentially insidious side effects and that research be spent on finding a cure.

I was a healthy 43 year old male. 12 days of Levaquin has changed my life. I had never had a side effect from a medication. This dangerous drug is in a different league.

My side effects from Levaquin include a deep ache in thigh, disabling tendon issues across achilles, groin, elbow, etc. I have tingling, numbness sensations, and muscle twitching. I need crutches now to walk, and some days cannot walk at all. This is my life now because of Levaquin.

While the black box warning issued by the FDA is a start, it doesn’t go nearly far enough in describing the seriousness nor the scope of the side effects.

It’s time to recognize the facts and not rationalize them away. Let’s not have more tragedies.

Anonymous said...

I was a healthy 38 year old before taking 10 days of Levaquin. Now I have joint pain, muscle twitching and pain, tingling and burning sensation of fingers and toes, multiple skin problems etc. etc..list goes on. Seeing different doctors to treat these side effects including a Nuerologist, Rhuematologist, Dermatologist etc. Unable to exercise due to horrible muscle, leg pains, I used to regularly exercise before Levaquin. Economic burden for last 6 months from the treatments too. FDA needs to take a look at this medicine again, just the black box warning isn't enough.

moonlight171 said...

My ADR to a fluoroquinolone derivative is similar to David Fuller's. Adding to the lists of cardiac, neurological, mitochondrial, liver, kidneys, life threatening hypoglycaemic attacks, a profound incapacitating weakness, cycling from moderate to very severe to the point of being unable to hold a glass of water. It seems that a many suffer from delayed reactions, and thus, not correlating their reactions to the medication. For those who are keen to find out about symptoms, please visit, lso, read up on all symptoms and good advice from http://www.fluoroquinolones.org/ and those who need a tranquil and peaceful forum to exchange info, tips, with a chatroom, we meet on Thursday nights, www.favc.info
or http://noquinolones.proboards58.com/index.cgi?action=display&board=quins&thread=728&page=1#2946

Sharon said...

I had surgery in 2000 to remove a urinary bladder stone caused by a previous unnecessary and unsuccessful surgery for minor stress incontinence. I was given Cipro for weeks prior to the surgery and after. I was told that the inside of my bladder looked like raw hamburger meat. I continued to get UTIs while the bladder surface was healing. I was given Cipro many times over the next 5 years by 3 different physicians. I was 60 or over at the time. I was told by 2 physicians that I needed to be on Cipro for a year. After 5 months in 2005, I stopped taking the drug since I developed severe ear pain. I experienced about 20 side effects, tendon rupture, neuropathy, sensitivity to noises, balance problems, rashes and itching, sun sensitivity, fatigue, vision problems, to name just a few. I'm still disabled and suffering. What in the world will a black box do? This drug needs to be withdrawn from the market.

Anonymous said...

My name is Leslea and I am a Clinical Laboratory Manager, have been a Medical Technologist for almost 30 years. I am very well respected by the medical staff at my facility because if I bring up a subject, perhaps a laboratory protocol that I want to put into place or changed, I have done my homework on the subject.
With that in mind, I want to urge physicians to take heed to the fact that fluoroquinolones are not safe for a very large segment of the population. There are literally thousands and thousands of people whose lives are forever changed because of the quinolones.
I know that most, if not all, facilities with microbiology departments put out an antibiogram, at least annually, for the medical staff to reference. Please use your antibiograms to pick the least toxic and most effective antibiotic for your patient.
Use the quinolone class only as a last resort, after other antibiotics have failed or the patient will expire if they aren’t used. Using the quinolones routinely just doesn’t make sense when other antibiotics will work. Keep in mind if this class of antibiotics continues to be used so nonchalantly they will become ineffective due to bacteria developing resistance to them.
I have personally experienced multiple system adr’s to the quinolones, and know a multitude of people like me. That is why I am writing this, I want to prevent the number of people that are damaged by quinolones from growing exponentially.
The adr’s to the quinolones are grossly under reported due to the fact that a lot of reactions aren’t recognized, but are diagnosed as an unrelated problem. If the number of adr’s to quinolones were accurately reported to the medical community, no physician would ever routinely prescribe quinolones again, unless he was some sort of sadist.
My motivation for writing this is honorable, our term would be risk management in the medical community, for the layperson it would be a passionate desire to prevent others from suffering like I am.
Just in case you are wondering, my first reaction to a quinolone caused damage to my tendons particularly my left knee. The tendons were so weak that my knee dislocated 6 times over a 7 month period, I probably should have been in a wheel chair, but I needed to work. I have a permanent baker’s cyst in that knee. The tendonitis was so painful that walking was more like hobbling.
My second reaction made my first reaction seem like a walk in the park. When I mentioned multiple systems earlier, I meant CNS, muscular, skeletal, soft tissues and connective tissue damage. Four and a half years post two doses of Avelox, I still have a multitude of symptoms, some that are not going to resolve. Although I am in severe unrelenting pain, I consider the worst part of my reaction to be the CNS or brain damage.
I have debilitating depression, which I never had prior to this. But the thing that takes the cake is the following: I am sure you can imagine that I am or actually was above average in intelligence, Avelox has destroyed my short term memory and has made me struggle to find simple everyday words when carrying on a conversation. My nickname used to be “The Steel Trap” because I never forgot anything and could recall verbatim conversations no matter how long or short the amount of time that had elapsed. My memory was what is called photographic in nature. You might be tempted to say, well you are getting older, well I don’t believe that CNS changes due to aging happen overnight unless there is a stroke involved. That, and the fact that I am not alone with this reaction, speaks very loudly to the truth of the matter.
I will quickly list the other damage I am dealing with; peripheral neuropathy, myofascial damage in my right hip that has lead to permanent gluteus median adhesions after tearing. I have chronic muscle spasms and knots in my right hip and shoulder, this is the cause of the severe unrelenting pain, the shoulder knots and spasms lead to horrible tension headaches. I also have to take Valtrex to keep shingles at bay, another wonderful symptom of the nerve damage. My tendons and ligaments in my right knee are tender to the touch and painful, my vision is altered due to floaters and blurring, luckily laboratories are notoriously noisy so I don’t notice the tinnitus too much. I could go on and on, but you get the picture. By the way, I was a healthy active person prior to this reaction, I was 47 at the time and most people would guess my age at 35 because of my personality, strength and agility, they were always shocked to find out how old I was.
Please help me in preventing any other healthy individuals from experiencing this nightmare.
I also challenge you to do your own research into the real picture of this class of antibiotics, quit taking the word of the FDA or pharmaceutical companies, they have an agenda, but it is less than honorable. You can start by going to www.fluoroquinolones.org .
Thank you for your time.

Anonymous said...

I don't get it, if people here are as sick as they say they are and have memory issues then how are they able to write as much as they do and do it with such articulation and lucidity?

david fuller said...

I don't get it, if people here are as sick as they say they are and have memory issues then how are they able to write as much as they do and do it with such articulation and lucidity?

Because most of them have been saying the same thing over and over and over and over and over and over again for a decade or more. But nobody is listening. As well as the fact that these are for the most part well educated, articulate individuals to begin with. Doctors, lawyers, executives, ect. People who have learned how to speak and write with clarity and do so without a second thought. They are not some hack reporter or drug rep that simply cut and paste what ever line of b.s. they have handed to them on a silver platter without doing any fact checking of their own.

More to the point if it was not for spelling and grammar checkers for the most part these post would be unreadable.

Others have labored for hours on end (or even days) composing thier comments before posting them or had family members assist them, or are using voice recognition software.

You also need to consider just because (in some cases) the body has been destroyed that does not mean that their brain has quit working as well.

Myself as a prime example. I have been dealing with this for two and a half decades. I killed more trees writing to anyone that I thought would make the slightest difference since 2000. Practice I guess makes for perfection. Lord knows I have had enough practice over the past eight years.

Jenn said...

In March I was given a gram of Cipro a day for a week due to a UTI. It is currently 4 months out, and I still cannot walk normally without pain medication because of the tendonitis in both my legs, not to mention also sudden stabbing chest wall pain that comes and goes, and earlier on, many neuropathy issues as well. My ADRs also did not appear until 2 weeks after I was finished taking the cipro, which made it harder to determine that was the cuase. It was only this week that a specialist was able to definitively tell me that cipro was the cuase of all my issues. A warning on a box does not make my problems go away, but hopefully it will make others think before ingesting this compound.

Christine said...

Here I sit over 25 months later from taking 4 750mg pills of Levaquin for a simple sinus infection. Here I sit in much pain with blurry vision. I've been in pain every day since day 3 of Levaquin. I wasn't given any warnings, just samples in my doctor's office, who, had been lied to by the drug reps about these fluoroquinolone drugs. I asked, "anything I need to know, any side effects"? "No" I was told, "these are great big-gun antibiotics". No, I have not had a tendon rupture but still have tendonitis in many parts of my body, my shoulder being so bad that my therapist is scared to work on it. My neck froze up 2 weeks ago leaving me screaming in pain and unable to drive. I suffered from severe insomnia, depression and thoughts of suicide, all drug related. I still suffer from many other ADRs including muscle twitching, nerve pain, osteoarthritis (never had this before Levaquin), floaters, gastro problems, liver problems, fuzzy vision, etc., etc., etc. My doctor has written "Levaquin toxicity" as my diagnosis. My neurologist agrees. This Black Box Warning is not strong enough! Tendon ruptures in people over 60 is just the tip of the iceburg! I was only 47 when I took this drug. I did not take it with steriods. This drug has ruined my life! It has taken 2 years from me and God knows how many more it will take. These drugs should only be used as a last resort! Please stop hurting people!

Levarel said...

I was 23 years old. My life was ahead of me and I was looking forward to it. I came down with simple, acute cases of bronchitis and sinusitis and was given 20 days of Levaquin as treatment. My life has never been the same.

I’m almost 27 now and have spent the last 3 1/2 years completely disabled and housebound. The list of adverse reactions I’ve experienced is too long to really post here, but includes severe non-abating tendon problems in every part of my body; muscle contractures; severe fatigue, depersonalization and short-term memory loss; peripheral neuropathy; circulation problems; gastrointestinal problems; anxiety with random, uncontrollable panic attacks; and some neurological symptoms that no one has been able to even diagnose. I was mostly unable to stand up for over a year due to severe problems with my ankles, knees and hips and can still only walk very short distances; I also require speech-recognition software to type and any sort of even mildly strenuous activity results in further injury.

Every doctor I’ve seen has concurred that Levaquin caused this, but none have been able to help me at all, despite the warning label on the drug saying to contact your doctor if you experience any of these symptoms. No one in the medical community can give me any idea of what my prospects for recovery are, nor can they can tell me what effect this ordeal will have on my health as I age.

While the full prescribing information lists nearly all of my symptoms as possibilities, it does not warn that they can last for years or even be permanent, that adverse reactions tend to appear in groups (many people report dozens of symptoms), and that such severe side-effects can appear weeks or months after the drug has been discontinued. The brunt of my reaction started approximately two weeks after I completed my course of Levaquin, worsened in many respects for well over a year and continues to this day. The vast majority of people who are prescribed these drugs assume that any side-effects experienced will resolve when the drug is discontinued and warnings that this is not the case are required immediately in order to provide some semblance of informed consent. The current situation is resulting in large numbers of people who are injured by this class of drugs, but have yet to uncover the cause of their ailments due to the delayed nature of these reactions.

Over the years, I’ve corresponded with hundreds of victims of these drugs, all with stories eerily similar to my own, and read thousands of such testimonials on the various websites devoted to these reactions. While these may be anecdotal reports, the correlations between them, the sheer number available and the severity of what is being reported more than warrant a thorough investigation into this matter. Informed consent is never too much to ask for.

This black box warning, while a step in the right direction, does little to prevent others from ending up like me and nothing at all to help those who are already here. The FDA has dropped the ball on this one (to put it nicely) and I can only hope that someone in either the medical or journalistic communities decides to pick it up again. No one deserves to have to go through what I have and especially not for infections that most likely would have cleared up on their own with some time, rest and increased fluid intake.

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david fuller said...

Though I had posted this on other sites dealing with this issue, it is still relevant to the discussion at hand and I would hope the host of this site would not take offense at me repeating it here:

In addition to the recent "Black Box Warnings" as well as the European "Dear Doctor" issued by Bayer overseas back in February 2008 concerning Avelox, the European Medicines Agency has moved to severely restrict the use of Avelox (moxifloxacin), to wit:

FRANKFURT, July 24 (Reuters) - The European Medicines Agency has recommended limiting the use of oral moxifloxacin-containing medicines after finalizing a review of the safety of the antibiotics, the agency said on Thursday.

The European body (EMEA) said it had concluded that these drugs should only be prescribed for acute bacterial sinusitis, acute exacerbation of chronic bronchitis and community-acquired pneumonia when other antibiotics cannot be used or have failed.

"The agency also recommended strengthening the warnings for oral moxifloxacin medicines," it said in a statement.

Moxifloxacin, a fluoroquinolone antibiotic, is marketed by Bayer (BAYG.DE: Quote, Profile, Research) under its brand Avelox.

At its July 2008 meeting, the agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of oral moxifloxacin medicines continued to outweigh its risks.

However, due to safety concerns, mainly related to an increased risk of adverse hepatic reactions, it recommended restricting their use in these indications.

The CHMP opinion will now be forwarded to the European Commission to apply to all oral moxifloxacin-containing medicines authorized in the European Union.

Responding to the recommendation, Bayer said the review confirmed the positive benefit-risk profile of the drug.

"We would welcome an EMEA assessment of other antibiotics used for treatment of these infections in a similar fashion in the interest of patient care," said Kemal Malik, a member of Bayer HealthCare executive committee and chief medical officer.

http://uk.reuters.com/article/governmentFilingsNews/idUKL2453307820080724

Black Box Warnings, Dear Doctor Letters, restrictions place on the use of Avelox, thousands of patients responding to these articles claiming severe injuries from this class, hundreds if not thousands of adverse drug reaction forums with tens of thousands of members world wide, as well as more than fifty percent of these drugs removed from clinical practice, and last but not least the fact that Nalidixic Acid, upon which all these drugs are based is a listed cancer causing agent, I dare to ask: are we still to believe the following comment which can be found at the end of just about any article written about this class?

'The fluoroquinolones as a class are generally well tolerated; most adverse effects are mild in severity, self-limited, and rarely result in treatment discontinuation...'

Or are we to continue wonder if we are the only ones who have bothered to do any research on this class in the past twenty six years. For surely who ever would make such a claim has not.

“Repeat a lie a thousand times and it becomes the truth ...” - usually credited to Dr Joseph Goebbels, Propaganda Minister of the Third Reich. I now credit it to those medical researchers who continue to state how safe and effective this class of chemotherapuetic agents are. For they have repeated this lie a thousand times a thousand times. Rather odd coincident that they are both (Goebbels, and these medical researchers who state such blatant lies) members of the medical community.

FattyMcFat said...

It's all in your head.

david fuller said...

Thank you fattymcfat for that astute observation. But you seem to have neglected the other organs damaged by this class. It is also in our hearts, livers, kidneys, muscles, ligaments, cartilage, the list is endless. But thank you just the same for that 'final word' on this serious subject.

Unfortunately it would be rather unfair to all those who have suffered to allow this blog to end on such a frivolous statement.

Though we just recently received a Black Box Warning for the Tendon Issues, it fails to address the concerns relating to muscles, ligaments and cartilage which is damaged in the same manner.

Muscle Damage & Tendon Ruptures
http://fqresearch.org/tendon_muscle_pain.htm

One of the most crippling adverse reactions is spontaneous tendon ruptures which may occur during as well as years after therapy. Such events have been reported since 1982. Tendinitis, arthralgia, myalgia as well as severe joint, muscle and tendon pain are one of the most
common adverse reactions. Cases of rhabdomyolysis (muscle death) with fatal outcomes are also being reported.

THEREFORE ADDITIONAL BLACK BOX WARNINGS ARE MANDATED BUT LACKING FOR THE FLUOROQUINOLONE CLASS OF CHEMOTHERAPUETIC AGENTS WHICH INCLUDE:

Levaquin
Avelox
Ciprofloxacin
Factive
Tequin
Floxin
Lomefloxacin
Cinoxacin
Enoxacin
Enrofloxacin
Fleroxacin
Norfloxacin
Proquin XR
Pefloxacin
Sparfloxacin

As well as numerous others drug names used overseas for these same drugs.

The following adverse reactions are life threatening and should require a BLACK BOX WARNING in addition to the one concerning the tendon issues, to wit:

Brain Damage
http://fqresearch.org/brain_damage_archives.htm

Pseudotumor Cerebri also referred to as increased intracranial ressure has been reported with fluoroquinolone therapy. Strokes are also a known adverse reaction. The effects of these drugs on
brain function is still under investigation. Hypoglycemia-induced anoxic brain injury has been associated with levofloxacin. Reported neurotoxic effects include insomnia, seizures, and psychosis.

Blood Disorders
http://fqresearch.org/blood_disorders_archives.htm

Serious and at times fatal blood disorders are a known adverse event associated with fluoroquinolone therapy. Autoimmune hemolytic anemia, bone marrow depression, abnormal blood coagulation as well numerous other disease states affecting both the white and red blood cells have been reported. Leukocytosis (white count increased) is often present as well as lymphocytosis.

Drug Interactions
http://fqresearch.org/drug_interactions.htm

The fluoroquinolones interfere with numerous other drugs, which may result in serious or even fatal interactions. The proper absorption of
concurrent medications may result in the medications not working or plasma levels reaching dangerous levels. The use of NSAIDS has also been reported as an additional risk factor in regards to tendon and muscle damage when taken with a fluoroquinolone drug.

Gastrointestinal Damage
http://fqresearch.org/gastrointestinal_archives.htm

Damage to the digestive system is one of the leading adverse events associated with these drugs. Nausea, vomiting and severe diarrhea are often times reported. Hepatotoxicity, pancreatitis, intestinal bacterial overgrowth, pseudomembranous colitis, liver failure are all
known adverse reactions to fluoroquinolone therapy. Hypersensitivity to food additives also contributes to digestive problems.

Hypo / Hyperglycemia
http://fqresearch.org/sugar.htm

Fatal blood sugar reactions are associated with the fluoroquinolones. Numerous drugs found in this class have been associated with cases of both hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar) that can be serious and fatal. We believe that such events are a class effect and are overlooked by the treating physician. Tequin is no longer manufactured for this very reason, but is still in clinical use.

Heart Damage
http://fqresearch.org/heart.htm

QT Interval Prolongation, Torsades de Pointes, and Ventricular Fibrillation, which may result in fatal heart attacks have been reported. Damage to the heart valves as well. Such events are to be considered a class effect. Moxifloxacin (Avelox) carries a far greater risk of QT prolongation than any other fluoroquinolone but was recently approved by the FDA in spite of this increased risk anyhow.

Kidney Damage
http://fqresearch.org/kidney_damage_archives.htm

Acute interstitial nephritis, acute renal failure, allergic nephropathy, renal vasculitis, nephrotoxicity and purpura are all associated with
fluoroquinolone therapy. Renal failure with fluoroquinolones is a very real risk with fatal outcome. Patients develop end-stage renal disease
and remained dependent on dialysis. Acute interstitial nephritis (AIN)may prove to be irreversible.

Liver Damage
http://fqresearch.org/liver.htm

Fatal liver damage may prove to be a class effect of the quinolone drugs. Severe liver damage resulting in liver transplants has been
reported. Trovan was removed due to such liver damage and is banned overseas. Acute severe hepatitis is also a known adverse reaction to fluoroquinolone therapy. Delayed, prolonged cholestatic hepatitis is also a severe adverse reaction to the fluoroquinolones.

Obstetrics
http://fqresearch.org/baby_archives.htm

Research indicates that the fluoroquinolones can rapidly cross the blood-placenta and blood-milk barrier, and are extensively distributed into the fetal tissues. Peak concentration in human breast milk is similar to levels attained in plasma. Breast-feeding mothers who take a fluoroquinolone will expose their infants to severe adverse reactions and pregnant women are at risk killing or damaging their unborn child.

Phototoxicity and Skin Damage
http://fqresearch.org/rashes.htm

Stephen Johnson Syndrome, toxic epidermal necrolysis syndrome, or T.E.N.S., a life-threatening skin disorder in which the top layers of skin blister and peel off in sheets, is associated with the quinolone class. The fluoroquinolones are a new class of photochemical
carcinogens with severe phototoxicity reactions. Severe disfiguring rashes are associated with Factive but the FDA approved it anyhow.

Rhabdomyolysis
http://fqresearch.org/rhabdomyolysis.htm

Rhabdomyolysis is the breakdown of muscle fibers resulting in the release of muscle fiber contents into the circulation. Some of these are toxic to the kidney and frequently result in kidney damage.
Rhabdomyolysis is a potentially life-threatening adverse reaction to fluoroquinolone therapy and requires immediate medical attention.

Seizures
http://fqresearch.org/seizures.htm

Risk factors for fluoroquinolone -induced seizures may include seizure history, electrolyte imbalances, dose unadjusted for renal
insufficiency, and concomitant treatment with agents that lower the seizure threshold. Seizures are common with all the drugs found this class though more prevalent with the newer quinolones.

Toxic Psychosis and Delusions
http://fqresearch.org/toxic_psychosis_archives.htm

Toxic psychosis may appear during fluoroquinolone therapy in patient's who do not have a prior history of psychiatric disturbances. The symptoms of toxic psychosis are aggressive or hostile behavior, paranoia, delusional thinking and auditory hallucinations. There have been reports of fatalities due to violent episodes, suicides, and homicides during and after fluoroquinolone therapy.

Urological Damage
http://fqresearch.org/urology_archives.htm

Hematuria (blood in the urine), crystalluria, kidney stones, as well adverse testicular effects are all associated with fluoroquinolone therapy. Chronic prostatitis/chronic pelvic pain syndrome in men is often times treated with fluoroquinolones even though this is not an approved use of the fluoroquinolones. Nor do we find the use of this class to be effective for treating sexually transmitted diseases.

Vasculitis
http://fqresearch.org/vasculitis_archives.htm

Fluoroquinolone induced hypersensitivity vasculitis as well as renal vasculitis are known adverse reactions with associated fatalities.
There is very little research in regards to this particular adverse reaction even though vasculitis is a suspect contributor to the many
reported spontaneous tendon ruptures. Such damage to the blood vessels often times appear as popular and purpuric lesions.

BLACK BOX WARNINGS ARE ALSO MANDATED FOR THE FOLLOWING REACTIONS WHICH HAVE A PROFOUND EFFECT ON THE QUALITY OF LIFE OF THE PATIENT AS WELL AS RESULT IN PERMANENT AND NON ABATING INJURY:

Anxiety and Panic Attacks
http://fqresearch.org/anxiety.htm

Anxiety and Panic Attacks are quite common with these drugs. Such events manifest soon after ingestion of just one pill. Extreme nervous
system reactions such as this are difficult to treat and the use of other drugs to treat these reactions often times fail. It has been suggested
that the binding of the fluoroquinolones with the GABA receptors in the brain may be responsible.

Arthritis / Fibromyalgia /Chronic Fatigue
http://fqresearch.org/arthritis.htm

Adverse reactions are often times misdiagnosis as numerous other rheumatological disease states. The patient will require a complete work up as these reactions mimic serious other diseases and such diseases have to be ruled out. There have been numerous reports of fluoroquinolone induced fibromyalgia as well as chronic fatigue. We
also find severe joint damage resulting from fluoroquinolone therapy.

Burning Pain
http://fqresearch.org/burning_pain.htm

Burning pain is one of the most common and serious adverse reaction to the fluoroquinolones. The name for this is 'Peripheral Neuropathy'.
Such pain may be irreversible and last a life time. It has been stated that the sensation is much like being soaked in gasoline. This pain
is the result of severe nerve damage and there is no known treatment for permanent nerve damage such as this.

Central Nervous System
http://fqresearch.org/cns_pns_archives.htm

Central Nervous System adverse reactions manifest as insomnia, seizures, tremors, taste perversions, and usually involves all five of
the sense: Sight, Hearing, Taste, Touch, and Smell. Ringing in the ears as well as vision problems including 'floaters' have been reported
as being permanent in nature. Insomnia may last for years as well resulting in additional problems due to sleep deprivation.

Depersonalization
http://fqresearch.org/depersonalization.htm

Best described as a sense of total detachment with one's life. Often referred to as "watching yourself live" as if you were watching a movie
rather actually taking part in your life. Such detachment results from fluoroquinolone therapy but is often times diagnosis as a psychiatric
disorder rather than a severe adverse reaction. Suicidal thoughts as psychotic reactions are common adverse reactions.

DNA Damage
http://fqresearch.org/dna.htm

The fluoroquinolones interfere with DNA replication by inhibiting an enzyme complex called DNA gyrase. This can also affect mammalian
cell replication. Although the quinolone is highly toxic to mammalian cells in culture, its mechanism of cytotoxic action is not known.
Recent studies have demonstrated a correlation between mammalian cell cytotoxicity of the quinolones and the induction of micronuclei.

Hearing Loss
http://fqresearch.org/ears.htm

Tinnitus (ringing in the ears) as well as total and partial hearing loss is yet another adverse event of a permanent nature. Loss of balance
due to damage to the inner ear has also been reported. Increased Intracranial Pressure (feeling of pressure in ears ) is another. In spite of the risk of seizures triggered by fluoroquinolone eardrops, as well as deafness, the FDA has approved clinical trials for pediatric use.

Kids / Pediatric Use
http://fqresearch.org/pediatric_research_archives.htm

The only indications for which a fluoroquinolone is licensed by the US Food and Drug Administration for use in patients younger than
18 years are complicated urinary tract infections, pyelonephritis, and post exposure treatment for inhalation anthrax. Fluoroquinolones
cause arthrotoxicity in juvenile animals and have been associated with irreversible musculoskeletal events in both children and adults

Sleep Disturbances / Insomnia
http://fqresearch.org/insomnia.htm

Sleep deprivation as the result of severe insomnia contributes to any number of psychological adverse events. Such insomnia has been reported to last for years in some patients. Sleeping aids have proven to be, for the most part, ineffective when treating fluoroquinolone
induced insomnia. Vivid dreams and even terrifying nightmares are to be expected long after fluoroquinolone therapy has been stopped.

Special Senses
http://fqresearch.org/special_senses_archives.htm

All five senses; hearing, sight, taste, touch and smell, suffer severe damage as a result of fluoroquinolone therapy. Taste perversions,
hearing and vision damage are most often times reported. This may be the result of nerve damage or vasculitis. Patients have reported a 'crawling' sensation as if there was something under the skin, loss of sensation and other such abnormalities.

Vision Damage and Blindness
http://fqresearch.org/vision.htm

Severe corneal toxicity, corneal deposits, irreversible retinal toxicity, permanent diplopia (double vision), floaters, cataracts, decreased
vision and even irreversible blindness are all part of the adverse reactions of the fluoroquinolones. Patients have reported numerous
vision disturbances to which the underlying cause cannot be found. Still these drugs are used to treat minor eye infections.

Now if all of the above is 'in our heads' we must have one helluva vivid imagination.

Steve said...

What did you guys do about the disability part? Were you able to go on SSI? How were you able to support yourselvs?

david fuller said...

Few if any victims were able to get on disability. Some have lost their jobs, their homes and even their marriages. Others simply take massive doses of pain killers and struggle thru the day the best they can.

It's a nightmare and a daily struggle just to survive. Some don't make it and end up committing suicide instead. Other than the tendon issues there really isn't any kind of documentation one could present for disability to begin with. Got to remember the overwhelming majority of the treating physicians do not relate these reactions to the fluoroquinolones, telling the patient it is all in their heads.

You also need to consider the fact that most of these folks are one paycheck shy of being bankrupct due to the medical bills. People simply do not have the funds needed to hire an attorney to get them on disability to begin with.

So they end up moving in with relatives for the most part. Or thier spouses go back to work and try to make ends meet.

Or as in my case you wipe out your life's savings, cash in your 401k, take out second mortgages I have no idea how I will ever repay, and max out our credit cards to pay the hospital bills. As well as my wife going back to work while in her fifties. Eventually I will have to sell my house and lose all the equity I have built up over the years as I simply can't put in the hours at work to pay for the medical care that I need that the insurance doesn't pay for.

I've worked my ass off for over forty years now and may very well lose everything in the very near future. All because of a damn drug and the surrounding medical ignorance.

Anonymous said...

if iam taking cipro and don't feel good, would blood work and a urine test show cipro in my body? or is the half-life too short or something?

Dr. Matthew Mintz said...

Blood levels and urine levels for Cipro are rarely used except for studies.
If you are taking Cipro and not feeling well, you should call your doctor ASAP.

Bob said...

Bob from Lincoln UK

I took 7 days of a 28 day course of Ofloxacin in November 2007
Had to stop the meds due to intense pain in my knees and shoulders.
4 weeks in: -
hardly walk with severe swellings in knees , ankles and hips.
6 weeks in: -
Toxic psychosis, depression, anxiety and suicidal thoughts
9 months in: -
Pain in joints and muscles, tendons popping in every single joint but worse in spine.
Chronic back pain
Worsening of pre existing Tinnitus
Burning sensations on hands and feet.
Flushing sensations
Bee like stings all over
Feeling of being cold even in hot weather.
Urinary problems
New symptoms manifest themselves every week
Symptoms are progressive and not transient as stated in the prescribing literature.
I am 43 but feel like 63.
If you have Prostatitis or any infection that HAS NOT been cultured refuse Fluoroquinolones until they can confirm its life or death, honest it is just not worth the risk.
BE WARNED YOU QUALITY OF LIFE MAY DEPEND UPON IT!!!!!!!!!!!

Anonymous said...

Thriving, elderly residents in long term care facilities, are a prime example of the devastating, residual effects of fluroquinolones. Yes, they survive their pneumonias and uti's but the obvious debilitating, one to two week out side-effects, even death, can not be ignored. This is all to common to the trained eye. A study should be done and soon. Where is the professional responsibility they deserve? RN MSN.

david fuller said...

RN MSN,

You are indeed correct. My father recently being one such victim. Eighty four years old and doing quite well in a long term nursing home for years. Died within a matter of days after being given ciprofloxacin of respritarory failure. We buried him last May, and the death certificate of course cited natural causes. He was prescribed cipro even though we had clearly indicated that he was NOT to be given any drug within this class.

Marsha said...

I believe the elderly can't tolerate Avelox(a quinolone)or Cipro,levoquin and the like. I too see nursing home patients die after these drugs more frequently then they do after penicillin, augmentin or vancomycin, etc. There is a debilitating effect that is unique to fluroquinolones. The research shouldn't be difficult. I've been in nursing for 32 years and it's criminal.

Jim said...

My wife has spent the last 12 months trying to get something of her life back after being devastated by the use of Avelox (moxifloxacin). Tendon ruptures are only one of the things to worry about with these drugs - she has severe skin problems that won't go away; severe insomnia that doesn't even respond to sleeping pills; pain in all her joints (comes and goes cyclically); muscle pain, profound weakness in the muscles; chronic fatigue; horrible dreams (when she does get to sleep) so real that she can't tell reality from dream; abdominal pain - food sits there like a rock; adn more.

The quinolones cause damage that lasts for years. It doesn't stop when you stop taking the drug. Furthermore, damage can show months and years after stopping.

The worst of it all is that doctors and drug companies dismiss all such claims on the grounds that "it can't happen". Antibiotics just don't work that way. ADR's just don't happen after you stop taking the drug - etc. So, people like my wife are being severely hurt by the use of quinolones every day. Doctor's don't listen to their patients on this and yet there is no one else more qualified to speak about what a drug does to them than the one who trustingly took it into their bodies.

Black box warnings? Window dressing! The drugs are poisons.

Anonymous said...

My mother died 34 days after the first dose of Levaquin. I watched her deteriorate day by day laying it to old age, and her heart problems. Her legs would no longer take her up stairs two weeks after she started taking it. Pain in her knees etc. After her death October 8 2008 I went to my Dr to schedule surgery to have a torn meniscus repaired.

I was given Levaquin IV just prior to entering sugery to prevent infection at the time of surgery. With in just a few days I knew my mother's death was as a direct result of taking Levaquin because I was exhibiting many of the same symptoms she had.

I am still 8 weeks later suffering from the devastating effects of this poison distributed like candy by doctors who refuse to see how dangerous this stuff is.

Anonymous said...

this entire class of drugs is severely toxic, with vast systemic DNA damage especially for fluid-sensitive cellular interractions such as connective tissue cells and neuro hormones. doctors that prescribe these drugs usually have no idea about the widespread reactions, so they are okay with giving it another try. doctors enjoy repeat business and affection if they get rid of your infection. so, they are motivated to use the strongest stuff available to kill the infections and get some new patients. but, as you can see from this unbelievable outpouring of numbers of damaged persons, that the time table for a real uproar is getting narrower and narrower, until the point that regardless of FDA whatever, that patients will not take these drugs beause they have heard so many horror stories. The end of the fluoro-q's and q's is coming within the next few years.

Anonymous said...

The information in this blog has been very enlightening. I took Cipro for 1 week in August 2008 (500 mg, twice daily). In late November, I had significant joint pain (wrists, elbows, shoulders) for about 1 week. Then, in mid-February, I experienced 1.5 weeks of extreme joint pain (fingers, thumbs, wrists, elbows, shoulders and collar bones). Also, even though I am not currently experiencing the pain, my joints do seem 'looser' than in the past. Has anyone else experienced cyclic espisodes like this? Has else experienced this 'loose' feeling?

Anonymous said...

I wish I found this before I put this poison into my body. I took it for 5 days and took myself off of it. I'm suffering from tendon pain, tingling and numbness in extremeties,sever insomnia, nightmares every single night and depersonalization. I've only been off of this poison for a week and am praying it doesn't get worse. But, considering its delayed reaction I don't have much hope.

This stuff needs to be taken off the market before more lives are ruined.

If you have any questions or anything helpful to provide, PLEASE contact me at cipropoison@gmail.com.

Anonymous said...

This doctor says he is trying to criticize the FDA, but he is also criticizing Public Citizen. He is wrong to do this, because they are doing something which doctors like him clearly aren't, and that's defending the public from drugs like cipro. I find that most doctors don't seem to apply any critical analysis to the drugs they prescribe. They just parrot the drug maker's ad copy. And then it's up to the patient to try to sort out the damage, as seen by the people posting here who have had to see multiple doctors after taking cipro. I myself am sitting hobbled on the couch with tendinitis caused by cipro. I got no warning from my doctor or pharmacist about this, so without Public Citizen out there working for me, I wouldn’t have had so much as this doctor's maligned black box warning in my favor.

I'd say to anyone about to take cipro, don't listen to doctors like this one, because they do not care about your welfare. You will be left dealing with the damage to your body, and left with reading crap posts like this one shucking responsibility.

Dr. Matthew Mintz said...

I am critical of both the FDA and of Public Citizen. I am critical of the FDA for adding a box, supposedly based on their own new analysis, without releasing that data. How am I as a physician supposed to make educated decisions without data. Based on the responses to this post, there may be more to the Cipro issue than the FDA is letting us know. However, withot data, it is impossible to make a decision for a patient.
I feel horrible for all of the people who have posted responses to this blog due to suffering from Cipro and similar medications. If this is truly a horrible drug, then it's the FDA's responsibility to let us know. The problem is that despite all these posts, based on the available data, the serious side effects from still Cipro are still considerably rare. The other issue is that in certain areas of the country, bacteria (particularly those that cause uriniary infections) are becomming resistant to other antibiotics, leaving physicians with few options other than Cipro.
Public Citizen does do some good work, but it also needlessly scares people about other medications. Crestor is a prime example. Sidney Wolfe spent countless hours trying to get the FDA first to not approve Crestor and then to pull it from the market. However, we now know Crestor to be one of the most potent as well as safest statins on the market. Public Citizen beleives that no medicine should be taken until it has been on the market for seven years. If a medicine is approved by the FDA, and I feel it's the best choice for my patient, I don't want them needlessly worried about a "rule" with little data to support it.
The bottom line is that there are no perfect pills. We need to prevent the pills that cause too much harm or too little benefit from being used. However, we also need to accept that there are some pills that may help millions of people but hurt a few in the process.

michael fudge said...

i was prescribed Cipro on Feb. 10th 2009 and 3 hours after i took my first pill my right ankle blew up. The next morning i went to see my doctor and i said look at this, he said its not related no chance blah blah blah u probably have a stress fracture in your ankle, so i want you to continue to take your script. Well i haven't been able to walk since. I started doing research on it and stumbled on all this..I cant believe he didn't say holy cow stop taking that Cipro now, no, he said its a coincidence, wtf???????I am getting an attorney..

Bob said...

This is a summary of my own story. After reading it you can assume one thing. i am reasonably educated and fairly adept. Through research and tenacity I have for my own part found what is the most plausible reason why i have fell off a cliff in terms of my health. I am not a doctor and do not profess to have any medical experience. I am an engineer and for the most part have spent the last 30 years as a very productive individual. I now face daily pain and misery of a myriad of adverse symptoms that cycle and prove to be stubborn in terms of my attempts to rectify the situation. The biggest and bitterest pill to swallow is the fact the patient information leaflet states that if you suffer an adverse reaction to this class of drug you must go to your GP and seek medical assistance. Every medical professional that I have spoken to all have complete ignorance on the subject to the adverse reactions and are clueless in terms of what to do and what to prescribe to get me better. On reflecting on these posts I hope that we have managed to raise awareness on the subject and you will alert you colleagues to this awful outcome.

Nottsfloxed Story

October 2007
• Developed pain when urinating. Visited GP who prescribed Ceclafor, pain went a couple of days later. (no culture verified)
• Two weeks later the pain returned but worse, was prescribed Amoxicillin which did nothing for the pain.(no culture verified)
November 2007
• Was told to go to The GU clinic and get evaluated (no culture verified) prescribed Ofloxacin for 28 days
• 6 days later lucid nightmares, extreme pain in knees and shoulders, bloody stools, very painful prostate, penis and testicles turn blue as if blood flow is cut off. Profuse night time sweating with low energy.
• Told to refrain from Ofloxacin but diagnosed with Reiter’s Syndrome and referred to Urology.
• Back to GP who disputed diagnosis and prescribed Diclofenac for arthralgia and myalgia.
December 2007
• Extreme dry eye, visited Opthalmist who diagnosed dry eye syndrome and told to go to GP to get Lacrilube and No Tears prescribed.
• GP concurred Reiter’s syndrome and prescribed 28 day course of Ciprofloxacin
• On reading that Ciprofloxacin was a Quinolone antibiotic, went back to see alternative GP who told me to throw medication in the bin as I am now allergic to all Quinolones.
• Severe back pain on top of joint pain, tested for rheumatoid diseases (all clear except for depleted thyroid function), hips now totally seized, involuntary swallowing.
Christmas 2007
• Developed severe insomnia, toxic psychosis, full body seizures, panic attacks, and deluded thoughts of suicide.
• Referred to mental health.
January 2008
• All joints now noisy with hips dislocating. Tendons dry and popping in every joint.
February 2008
• Urologist refutes diagnosis for Reiter’s Syndrome and diagnoses chronic non bacterial prostatitis. Ordered up Cystopscopy (clear of bladder infection)
• Referred to Rheumatologist, who diagnosed nodal arthritis and overwork syndrome.
• GP prescribed Arcoxia for arthritis, Amytriptoline for insomnia and Omerprozole for bad acid reflux.




March 2008
• Cycling of pain every few weeks, tested for food intolerances positive for Wheat, gluten and Cows milk.
• Referred to Psychiatrist diagnosis mild depression as psychosis symptoms no longer a problem. Went through past medical history with medications and drug abuse!!! to establish if cause was drug induced.
April 2008
• Urinary problems dark smelly urine even when totally hydrated, urine sample taken, blood in urine (no culture verified).
June 2008
• Thyroid test repeated and now normal
• Vitreous floaters very noticeable.
• Referred to Ophthalmic clinic where vitreous floaters concurred.
• Read up adverse reactions to Quinolones found Flox report.
September 2008
• Referred back to Rheumatologist, he refuted Quinolone toxicity syndrome even after showing him Flox report and dear doctor letter, but ordered up MRI. All back normal no diagnosis for clunking joints apart from normal wear and tear.
• Back to GP Blood pressure now abnormally high.
• Prescribed Ramapril, developed cough and runny nose
November 2008
• High BP prescribed Felodopine along side Ramapril, developed asthma
January 2009
• Solvents cause chemical sensitivities.
• Intolerance to pepper and spices, digestion of these food stuffs increase smell perception of perfumed products.
• Prescribed Bendroflurothiazide caused blood sugar problems with extreme thirst
March 2009
• Developed Reynard’s phenomenon
• Intolerance of Chlorine in public baths. Severe dry skin and flaking when exposed.
• Prescribed candesartan cilexetil set off major CNS problems and increased anxiety.
• Prescribed Atenolol that set off prostate pain, severely reduced blood flow to extremities and exacerbation of drug induced asthma.


April 2009 - seventeen months out
• Major relapse with anxiety through the roof with involuntary swallowing, clicking and tendons popping like crazy. Severe tendon pain in feet, shoulders and knees. Deep aching rheumatic pain in hips, Aching back, Buzzing and vibrations through out the body, muscle facilitations in all sectors of the body, burning neuropathy in hands and feet, bee like stings all over the place, vitreous floaters increased with bright flashing lights, lumpy muscle pain in neck and Candida rife throughout my body.

Summary
There is a complete denial and or ignorance by the medical profession that this syndrome exists. Most minor medical staff has never heard of a Quinolone.

Care providers I have seen in the last 17 months who do not have a clue and or were unwilling to listen.

• Consultant Rheumatologist Head of Department, (after supposedly consultation with the most eminent doctors at a major Hospital)
• Urologist
• Psychiatrist
• Orthopaedic surgeon
• Ophthalmic Surgeon
• Four GPs
• Emergency Room Consultant
• Practice Nurses.

As you can see this is not a transient condition as it seems to suggest in the PIL. There was no mention of permanent anywhere.
Thanks in advance for you time in reading this post.
Bob P

david fuller said...

It has been a while, Dr. Mintz, since I had visited your blog here.

This time it is to report the death of yet another relative from these drugs. My aunt recently passed away within one week of being prescribed ciprofloxacin for a suspected sinus infection. She died of multiple organ failure as a result. She was in her eighties living in an assisted living facility and was extremely active for her age. In fact on the Monday before she died she had beat the pants off some the assisted living staff and other residents at the local bowling alley.

She went to the doctor with what she thought to be minor head cold, which in the elderly is nothing to fool with.

By the following Monday she was dead. Autopsy showed no apparent infections.

Anonymous said...

Someone please answer my concern? I realize many variations occur.In general, does the degree of risk tend to follow the duration of taking cipro? After 11 days cipro, I have a calf muscle tear and aches (not pain) in both calves and heels. Under Ortho care but trust you guys more. After wk nothing, no better/worse.Am not again running/exercise until the sensations quiet and just walk.Is worst over?Give it another wk?Mo?

homer80 said...

All of us Floxies must understand that in the mind of the medical community represented by Dr. Mintz we are the substrate of their world that should be grateful for the benevolence bestowed upon us by them. This arrogance is systemic in nature and a product of our overall medical philosophy, it is unlikely to change quickly so warn others and watch out for yourself and your loved ones. They are the captains of the titanic and we are all locked in steerage. It is an insult to humanity that such a compound is prescribed WITHOUT RESTRICTION even if only a small percentage is seriously effected. History will show these people for who they are, blindly arrogant, putting profit before people, ruining thousands and maybe millions of lives. They will not be able to escape their legacy or the responsibility which will define their existence by citing the PDR. As long as I have breath in me I will speaking out against the system which created this holocaust and working for change. There are good doctors out there and someday I hope there will be more because of this travesty.

Willow said...

Your ignorance is astounding, as is the ignorance (or perhaps denial) of most of the medical establishment regarding adverse reactions to fluoroquinolones. The tendon issues are actually the least of the problems. I took Cipro nine weeks ago and have experienced and continue to experience toxic psychosis, constant bombardment by morbid thoughts, trouble speaking, terrifying visuals when I close my eyes, vision problems/out-of-sync eyes, blinding headaches, facial flushing, chills, extreme exhaustion, dizziness, as well as tendon problems and weakness all over my body. I see tendon rupture mentioned as a possible "rare" side effect but very infrequently see any mention of the adverse affects on the nervous system - longlasting and very common. Neither doctors nor pharmacists warn of any of these symtoms, which many people have had to live with for years afterward. Anyone continuing to prescribe these drugs is sickeningly irresponsible. www.fqvictims.org

Anonymous said...

While all of my concerns and opinions have already been expressed, I feel it is my duty to post my agreement. At the age of 27, my healthy/athletic life changed dramatically.
While the medical community and FDA claim that these terrible reactions - which by the way, are not equivalent to stomach upset - are "rare", I believe that they are not. Soft tissue/tendon issues can occur up to 6 MONTHS after discontinuation of the drug. Anyone with half a brain would realize that this means that it is VERY possible that a great deal of side effects are NOT even associated with the drug. For example: Coincidence that the rate of Fibromyalgia diagnoses is growing at a similar rate of fluoroquinolone prescriptions? Fibro is thought to be caused by one of three things - one of which being prior infection/sickness. Correlation is not always causation... right Drs and PhD'ers? Many of these people took a fluoroquinolone for their infection, which caused the fibro. Fibro is only one of the misdiagnoses that may be associated with fluoroquinolones.

Anonymous said...

You're a f'ing idiot. Read everyone elses' comments to find out why!

L G Lindsay said...

For the past two years I have consulted the internet as if the internet were the Oracle of Delphi, and I, a disfigured leper. I look for any understanding that explains my altered consciousness, sleep disruptions, countless unprecedented daily assaults on my former healthy self both major & minor, and near disablement --- all following three x levaquin pills @500mg. I have looked at possibly five thousand e-postings and maybe 50 fee-free ("gratis") medical research articles to look for the causal relationship between fluoroquinolones (FQs)and quinolone toxicity syndrome (QTS). I have consulted every quin-related blogsite, URL, and medical research clearing house imaginable. To no avail.

You'd think I was a seven-year old trying to gain admission to a brothel: the bouncer tells me to come back when I'm old enough; and Johns who leave by the side door try to assure me there is nothing worth seeing. Such is the open state of dissembling by the medical class. Patients are expected to disregard their own intuition re: a link between FQs and their very disturbing, often multi-system breakdown shortly after having ingested a couple of antibiotic tablets prescribed for a minor ailment.

Are we living in an age when physicians still prescribe blood-letting by means of leeches? Must we buy plenary indulgences from pharmaceutical marketing reps who forgive us our sins of disparaging their employer's reputability but decline to offer us an antidote for QTS or even concede its existence?

You know there's an unholy alliance between toothless regulators and a marginally-regulated prescription drug industry that cannot allocate even a small purse from its billion dollar revenues to provision and task a small public relations outreach dept with educating front-line physicians about the more hideous and possibly irreversible adverse side effects associated with cipro and levaquin.

Ah, but, I forgot about the "invisibile hand of the market," that most excellent guide which enforces market discipline and assures corporate entities will self-regulate or go out-of-business. No need for a muscular FDA, there was'nt any muscle at the SEC! (But we digress.)

Having consulted numberous doctors and specialists only to hear patronizing denials about the likelihood with which a commonly-prescribed antibiotic that altered my DNA and genetic make-up remotely had any causal relationship whatsoever in my present disablement, I sense that
ignorance and charlatanism thrive in equal measure in a medical establishment intoxicated by its own self-importance and insulated from the street through the connivance of the medical insurance industry. Imagine spending 17% of GNP for the pleasure of hearing multi-syllable, vaguely Latin-sounding neologisms about newly-hatched pharmaceuticals that might disable or kill you without leaving a trace: Levofloxacin.
"Thanx, doc, let's forget about the pills; please pass me the leeches!"

Bruce Thomas said...

In May 2008, I was put on Cipro for one week for a UTI (by a doctor covering for my doctor) and then 2 weeks later put back on it for 2 weeks by my doctor, who said that one week wasn't enough. Six weeks later I was given two cortisone shots to my right knee (for a Baker's Cyst), and a week later I woke up one day with all of my joints on fire (every joint except my ankles). This was four months after my initial dosage of Cipro. My condition deteriorated rapidly for the next two months to the point where I could not lift my arms above my shoulders, could not open a water bottle or pill bottle, could not wash my hair or under my arms, could not even tuck in my shirt, etc etc. I couldn't sleep for weeks at one point because on the rare occasion that I could fall asleep, I would shift and wake up feeling like I was being stabbed all over.

I was a perfectly healthy 57 year old man at the time, and this came on like someone flipped a switch. I am a professional pianist, and had to stop playing the piano for three months. I thought my career was over. No doctor I saw would admit that there was any connection between the drug and my instant disabilities. Two different rheumatologists tried to get me to take prednisone (yeah, that's what I needed, another steroid) and one of them cautioned me against "self-diagnosis" when I brought up the Cipro, even though he couldn't come up with a diagnosis himself. The best he could come up with was "it was like rheumatoid arthritis, except without some of the usual normal markers."

LONG story short: it has been 22 months since my initial dosage, and 18 months since the onset of symptoms. I am about 90% recovered (as far as I know), and I am convinced that I only pulled through it because I was in such good health when it happened. How did I do it? Several months of acupuncture (mostly geared toward detoxification), chiropractic (which helped take the pressure off of my joints), Reiki (which gave me the most instant pain relief), and turmeric (the oldest anti-inflammatory known to man), bromelain (an enzyme from the pineapple) and some NSAIDS.

I can play the piano again, though my hands are not totally normal, as there are tendons bulging in the palms of my hands, which affects my hand-stretching ability at the piano.

Don't expect a lot of help from doctors; they will not admit to much because of fear of lawsuits. My doctor has opened his mind to this situation quite a bit (to his credit), and told me last month that one of the leading ENT specialists in the Northeast ruptured his Achilles tendon during some light biking while on Cipro, and he is attributing it solely to the drug. It is a shame that it will take doctors themselves becoming victims of this drug before they will take a stand against it. The drug companies made over 2 billion dollars on this class of drugs last year alone, so don't expect any cooperation from them on this. The FDA should be ashamed for letting Big Pharma push them around for at least ten years. They were either weak or corrupt or both, and many peoples' lives have become a living hell as a result. Someday these drugs will be banned. Things will probably have to get a lot worse before they are, but it will happen eventually.

Maybe you are among the majority who don't 'appear' to have a reaction to these drugs so enjoy its benefits while you can. When I first told my doctor of my suspicions, he said, "The drug should have been out of your system in less than two weeks." Ah yes, but the DNA it altered isn't. It says on Bayer's own website that fluoroquinolones alter your DNA. That says to me that anyone who has taken these drugs are not out of the woods until they are dead, which is what I'll have to about be before I take this drug again.

Generic Cipro said...

In my family, I have had two grandparents who had tendon ruptures from fq antibiotics - though the doctors denied any correlation between the meds and the tendon rupture- and many years later I have had terrible ongoing adrs from 4 days of ciproflaxin for a sinus infection.

Anonymous said...

Dr. Mintz, this is not a new or novel approach to say drugs are dangerous. It is parroted by each and every doctor as though it means anything. But my surprise is how you do not grasp the actual stated percentage. Even just the 2% that the manufactures will admit to shows a scary amount of left unreported. That would be 20 in a 1,000 or 2,000 in 100,000. And that is just one type of the over 50 ADRs fluoroquinolones are listed on the NDA to cause. What does the fact that most drugs are unsafe have to do with how unsafe quinolones are? Do two, three, or even four hundred wrongs make quinolones any more right?

Nikki M said...

Dr. Mintz,

I find your cavalier attitude about the unimaginable destruction of people's lives to be unfathomable. To say that we may need to accept pills that "may help millions but hurt a few in the process" is COLD. Do you enjoy your free time Dr. Mintz? Do you enjoy snuggling up to your kids? Taking a walk in the park on a warm summer day? Do you appreciate using the bathroom all by yourself, you know... like a big boy? I wonder if you can even appreciate how lucky you are that you haven't become an INNOCENT victim of BIG PHARMA, that you haven't had your life destroyed and discounted as a necessary sacrifice for the greater good. It's not your fault, right? You aren't to blame, right? Until the FDA says not to do it, what choice do you have? Right? God forbid you do the right thing. God forbid you help people like us. God forbid you think for yourself, take a stand, or give a shit.

Help millions and hurt a few? Are you kidding me? That isn't ignorance, the truth is right in front of you! That is denial. The truth can be so inconvenient, I know, but the truth is out there and it tells a much different story than what you hear from the FDA or read in your medical journals. I hope you will consider your options more thoughtfully and make some new choices about what kind of doctor you will be.

Dr. Matthew Mintz said...

Nikki,
I disagree with your statement that saying we may need to accept pills that may help millions but hurt a few in the process is "COLD." Penicillin is a perfect example. Allergic reactions to penicillin and similar antibiotics kill or harm a handful of people every year, but also save thousands of lives each year. It is not "cold" to think that we should have penicillin available to patients.
I believe the real question is whether cipro and other quinolone drugs fall into that category. Prior to the this post and the FDA's decisions, based on information that was publicly available, physicians and patients were led to believe that Cipro was safe. My original reason for this post was that the FDA seemed to change their stance on this from pressure for an advocacy group, without providing any meaningful information to back up the decision. At the time, I believed that meaningful data was not provided because it was lacking. However, after reading so many of these post, and hearing directly from patients who have been harmed, it now appears in fact that the FDA may not have provided meaningful data not because it was lacking, but rather because it was so abundant they wanted to cover up their error.
More to come on this.......

Nikki M said...

Thank you for the response and I am curious to see what is to come...

Just to clarify (because I was not very clear in my last post), I felt your remark was "cold" not so much because keeping a drug on the market that is generally safe is a good or bad idea, but because of the ratio you used (millions to "a few"). Discounting our numbers as "a few" is not accurate and in the face of so much evidence to support that inaccuracy, I feel it is "cold" to make such a reference. It further dismisses a whole population of people whose lives have been ruined by fluoroquinolones and who've most likely already been dismissed by a whole team of doctors.

We ARE an entire population, in fact, our population is most likely substantially larger than we can imagine. How many patients have gone to their doctor with a claim that they took a fluoroquinolone and soon after developed a mysterious condition: pain in the joints, sensitivity to the sun, sore ankles, poor digestion, fatigue, depression, burning sensations, pain, etc., only to be told, "it wasn't the medication, there is just something else wrong with you"? Those patients walk out of the office believing their doctor and they don't report it. And those dismissed patients are just a drop in the bucket of non-reporters and those who are totally unaware.

So my comments were not so much against keeping a sometimes risky drug on the market, but about downsizing this very real and very large group of victims to a negligible "few".

I apologize for creating the confusion, obviously my lack of clarity came from an over abundance of emotion. I get a little (or in this case a lot)prickly toward doctors who easily dismiss the importance of these labels or the realistic numbers of us that have been adversely effected.

I will look forward to seeing how your perspective on this issue concerning the FDA is shaping.

Anonymous said...

Your an idiot. I hope you get an infection. Be sure you take all of your levaquin. Being a dr doesnt make you special. It makes you the fourth leading cause of death.

The Barrow's said...

My husband is a cipro victim. He took Cipro and had an instant bad reaction but didn't correlate it to the drug until he'd taken 10 pills. So far he has missed 3 weeks of work and is on zoloft and xanax. Our doctor thinks it was the cipro. I was talking to a nurse friend who mentioned all the muscle pain/tendonitis she had with cipro. She asked a hospital pharmicist and he confirmed that cipro causes that. Most people think about antibiotic reactions as hives or a rash. Patients need their doctors to say "if you have....then STOP taking this med immediately!"

Falcon222 said...

I think the issue is being missed entirely. This horrible "antibiotic"/chemotherapy is deadly. There is a difference between say penicillin and the "chemotherapeutical" drugs like the quinolones aren't there? Isn't one totally synthetic while the other is totally natural? That is to say that the base compounds are one being from the nature and the other being from the lab? How are bodies supposed to know what to do with synthetics?

Anonymous said...

I have had 2 experiences with these drugs, first was Levaquin for a UTI. The tendons in my left foot and heel were extremely sore and dangerously tight, could not walk normally for over a year. They did heal with no help from doctor who did not believe the drug had anything to do with it. Second event was 4 years later with Cipro early 2011 for a recurring staph infection. My right shoulder started to go "tight" after day 2. I had told my doctor I did not want to take this type of antibiotic and she said it was "fine, don't worry!" It has been 4 months and have learned this: DO NOT EXERCISE OR TRY TO STRETCH OUT THE TIGHTNESS, use ice 4 times a day, let the arm (joint) rest - I used a shawl to make a comfortable sling, and use the joint very carefully. For 3 weeks I was sure I would have the tendon snap. I flushed with water, took a liquid B vitamin complex, used dry skin brushing to stimulate lympatic flow, and used probiotics every night. The pain when trying to raise my arm or hold a glass of water would make my eyes water. I began to have 3am extreme migraine like headaches. I am 62 and do not think these drugs are good for older people and will not take them again. My doctor sees no relation.
When I filled the Cipro prescription, the small town pharmacist mentioned she had been filling more Cipro the past 2 weeks than the year before. My thought was "the drug rep had just been through with a prize for who prescribes the most." I just added chiropractic to my personal Save The Tendons campaign and have made progress. Expect another 3 - 6 months to be able to use my right arm naturally again. Go slow, be gentle, best wishes to all who have suffered.
I always use alternative means to get well especially since doctors have no belief in the damage the drugs do and offer no help for the problems. Also, a physical therapist tried to get me to stretch this shoulder, he was unaware that NO EXERCISE is essential to prevent a complete tear or further damage.

Jeff Brown said...

Anecdotal experience in support of the dangers of Quinolones - Prior to 3 Levaquin 500MG I took out of the 10 prescribed for Pneumonia I skied 40 days+ a year (black diamond only), played tennis 4 days a week, rode Open Class Dirtbikes, etc. Within 24 hours of taking the Levaquin I was barely able to walk with the assistance of crutches. Ankles, knees, elbows, and shoulders all effected - couldn't even play guitar.

Now, seven months later, I can walk, but my knees and ankles are damaged to the point unless something improves remarkably the best I can hope for is shuffleboard. Didn't rupture a tendon - the drug took me down so hard and I figured out what was happening (thanks Internet) soon enough I was able to become sedentary to avoid further injury.

FDA forms have been filed and I have a good rheumatologist, but I would say the regulatory authorities should take a good hard look at the cost/benefit ratio of this medication. I personally suspect incidence of problems is much higher than published.

Donna said...

My 19 yr old son is in horrible pain right now after 3 days of cipro.

k.a. said...

I highly doubt you will read this (there are so many comments on this post), but as I type this, my ankles are roughly twice their normal size, elevated on a chair beside me. I am a slim 26-year-old woman with none of the risk factors associated with Cipro and no complicated medical history. I didn't think twice about it when the ER physician prescribed it for acute infectious colitis. I saw the couple sentences at the top of the prescription pamphlet, thought I wasn't in the vulnerable group, and just took the pills.

I didn't notice anything until a week later, when I woke up to ankles I could not even recognize as my own. Pain and unbelievable swelling.

So hello. 1 of this so-called rare group. I'm afraid to walk for fear I will rupture a tendon. I am sorry to say that even healthy young adults with no previous tendon trouble are at risk here and need to be warned.

Anonymous said...

Another FQ victim here. I received Levaquin for 10 days to treat a severe pneumonia. I had paresthesias in my hands and feet immediately, followed by pain in the tendons of my hands, feet, and ankles. About 1 week later, I bent over and heard a snapping sound with excruciating pain as a muscle tore in my mid back. That injury took about 8 weeks to "heal". Then after about 7 or 8 more months, pain returned in all of my tendons. (Hands, elbows, shoulders, hips, knees, ankles, feet). I continue to have diffuse tendon pain as well as debilitating back pain from the initial injury during FQ therapy. I take pain medications every day and struggle to perform daily activities. Before the levaquin, I swam laps every day and was in excellent physical condition. I have 30 pounds of unexplained weight loss and my health is literally destroyed. This is not rare!

By the way; I am also a physician. I undersatnd the differential diagnosis here and I have already been "ruled out" for just about everything else except the diagnosis of exclusion-Fluoroquinolone toxicity syndrome.

Mary said...

Okay i am very very freaked out about this. I have a sinus infection and i've been on two antibiotics before this one. My doctor wanted to put me on cipro last week so i did take it but then i read this type of stuff and stopped after one dose. Now my sinus infection is really bad i've talked to two doctors and my doctor at home (im in college right now) says that cipro is exactly what i need because all the other antibiotics i was on clearly were not working. I am still very hesitant to take them because to be honest i don't want to be crippled. Unfortunately i am allergic to penicilin and tetracyclin (yay me) so that means i cant take those, which would be perfect for this. Dr Mintz you mentioned bactrim? Do you think that would work for me? I'd much rather take that than take cipro. And apparently cipro causes psychological issues and i already have anxiety issues. I'd only have to take cipro 500 mg a day for 5 days. I do have a plan if i have to take it. I will not do any strenous exercise and i will take care of my tendons so they dont break on me. I just don't know what to do, i dont want to take cipro but the doctors are making it seem like its my only option. Is it really my only option if i'm allergic to penicilin and tetracyclin and biaxin didn't work? And what if my tendon ruptures and my doctor is like its not the cipro...keep taking it? There HAS to be another way to get rid of my sinus infection....i do not want to be crippled.

Dr. Matthew Mintz said...

Mary,
I can't give you specific medical advice without knowing your whole history or situation. However, if you are an otherwise healthy young woman and truly have a sinus infection, Bactrim is a good option. Pencillin and Erythromycin based drugs are usually the first line treatment for sinus infections. Sounds like you are allergic to the first and the second was tried and didn't work. Alternatives include cipro and bactrim, which are both good options. Since there are some concerns with cipro and not with bactrim, this seems like a reasonable choice. See the link below from aafp. Though a few years old, it doesn't even include Cipro as a treatment.
http://www.aafp.org/afp/2006/0915/p956.html

Mary said...

Okay i am on bactrin and its working well thank you so much for suggesting that i was almost put on levaquin (which is even stronger : /), anyways i do have some things to say on your article. I cant say for sure how common tendon rupture is among patients who take cipro no one really can because as stated the reporting system for adverse affects is not very good. So far its been established that 1/100,000 people suffer from tendon ruptures and thats pretty low .001%. I think if you need any flouroquinolones for an infection and you have no other option then its important to take that risk. Are you really going to die instead of taking a drug that may not even rupture your tendons, i'd rather be a living cripple than be dead and if anyone disagrees i feel sorry for them for not making the best of every situation (if you don't believe me look up Sean Stephenson he's a good example). I do understand though that if you are one of that .001% or whatever the figure really is, this being said doesn't really help and you do have a right to be angry at the drug companies. Furthermore, I think that these drug companies that produce flouroquinolones need to establish who is most at risk for tendon ruptures when taking these. An obvious one is people with bone disorders and the elderly and those with compromised immune systems but that doesn't really cut it. Very healthy people are ending up with tendon ruptures because of these medications and thus it is the FDA's responsibility to get to the bottom of it. I don't think these drugs should be taken off the market because they can be life saving and very helpful but i think its so important to find out what causes the tendon ruptures. So doctors can properly assess the risks of giving this antibiotic to their patients. It's not like these tendon ruptures are happening to every single person who takes them its only a relatively small percentage (possibly more) and that percentage must have some things in common which makes them more susceptible to tendon ruptures. So i guess i am taking middle ground on this, because i cant call a drug that has saved many lives poison for everyone. Though i will admit this, for every antibiotic i read the side effects and cipro was the scariest. Personally i don't want to take them until the drug company has answered these questions so i can confirm whether or not i'd be at risk for rupturing any tendons. To all people who have suffered problems from the flouroquinolone antibiotics, i'm very sorry this has happened to you but don't let that stop you from having a happy life (seriously look up Sean Stephenson he is really inspiring and has brittle bone syndrome, meaning he was born with weak bones and rupturing tendons). Anyways hopefully a new batch of antibiotics will come out which have less daunting side effects.

Anonymous said...

I'm in my early thirties. I'm a big but trim guy, and enjoy(ed) an active lifestyle with no prescription or recreation drug use, ever. Over a year ago, I had some breathing problems and was prescribed several antibiotics including a zip pack. Not seeing any improvements, the Doctor gave me the "heavy-artillery antibiotic" Avelox. A few days into use my entire body hurt from jaw to toe. For weeks, walking down my wood stairs sound like popcorn bouncing off the floor from all the cracks in every one of my joints - the sound would wake my household up. As that subsided, the limitations did not. I still cannot run a mile every few days where I could run three miles flat anyday, prior to this poison. I can't give my kids back rides, pick them up, or get down to play with them. Sitting hurts. Standing hurts. Sleeping hurts. A full year now...insomnia, depression, thoughts and fears I can't face.

Ironically, it was an allergy mint soap that had made my breathing so bad & irritated. Where was the warning on my sample pack of Avelox? Where was my unbiased consult? Why did my doctor even have sample of something like this without TPI??? Where was the form like those used for immunizations that would get a signature of Dr and Patient clearly exposing risks? Why isn't there a questionaire to cover use/don't use risk groups have you ever experienced... (liver problems? have weak tendons?)???

My opinion and personal experience. The under-feared fluoroQuinolone - has many many names, Levaquin, Avelox, Cipro, etc... beware. Beware! BEWARE!!! This drug *muste* be reserved for death bed pneumonia or bacterial prostasis only.

Anonymous said...

I'm in my early thirties. I'm a big but trim guy, and enjoy(ed) an active lifestyle with no prescription or recreation drug use, ever. Over a year ago, I had some breathing problems and was prescribed several antibiotics including a zip pack. Not seeing any improvements, the Doctor gave me the "heavy-artillery antibiotic" Avelox. A few days into use my entire body hurt from jaw to toe. For weeks, walking down my wood stairs sound like popcorn bouncing off the floor from all the cracks in every one of my joints - the sound would wake my household up. As that subsided, the limitations did not. I still cannot run a mile every few days where I could run three miles flat anyday, prior to this poison. I can't give my kids back rides, pick them up, or get down to play with them. Sitting hurts. Standing hurts. Sleeping hurts. A full year now...insomnia, depression, thoughts and fears I can't face.

Ironically, it was an allergy mint soap that had made my breathing so bad & irritated. Where was the warning on my sample pack of Avelox? Where was my unbiased consult? Why did my doctor even have sample of something like this without TPI??? Where was the form like those used for immunizations that would get a signature of Dr and Patient clearly exposing risks? Why isn't there a questionaire to cover use/don't use risk groups have you ever experienced... (liver problems? have weak tendons?)???

My opinion and personal experience. The under-feared fluoroQuinolone - has many many names, Levaquin, Avelox, Cipro, etc... beware. Beware! BEWARE!!! This drug *muste* be reserved for death bed pneumonia or bacterial prostasis only.

Anonymous said...

I was given Cipro to treat a Staph Aureus infection following surgical repair of a hernia. On about the 7th day, when walking up stairs, my right ankle/foot made a popping noise and it was painful. This happened two or three different occasions over the course of a few days (two different areas on my foot) and then a week later, after I was already finished taking Cipro, it happened in my right knee.

I mentioned it to my doctor, and he seemed unconcerned. I mentioned it again to the nurse and she said tendinitis reaction to Cipro was rare and so it probably wasn't the case for me, but to take it easy if that makes me feel better. And now I read this adverse reaction can persist or pop up months after taking Cipro. I'm just a little frustrated :(

The Staph A infection following surgery was "rare" (so I was told) as well as the incarceration of intestines in the hernia which caused me to have surgery a few weeks later (that was supposed to be
"rare" for it to become incarcerated).

Jessica

Frankej said...

A very old article from July 1998 clearly describes the impact of of fluoroquinolones including cipro on tendon fibroblast metabolism in vitro. The authors found a >50% reduction in key processes needed to maintain a healthy tendon.

My Achilles tendon ruptured at age 45 after several sporting activities. Due to allergies Cipro is one of the few antibiotics I can take and this may have contributed to the rupture event. According to stats 6% of rupture events might be attributed to Cipro in those that take the medication. I am sure this is scientifically hard to estimate due to poor reporting and association of drug to events like this. I had no other associated side effects with Cipro. I still use it. I am still very active in sport, however, I am very careful to do strength exercises to reduce the risk of repeat rupture. I now have pneumonia and am on Cipro 500mg twice daily.

It is clear that some medications are dangerous in certain populations due to genetic differences. Different populations require different drug doses due to genetic differences. Studies are needed to identify these genetic risk factors and provide future low cost screening to identify those individuals that may be benefit or potentially be harmed by a medication.

http://ajs.sagepub.com/content/28/3/364.short
The Effect of Ciprofloxacin On Tendon, Paratenon, and Capsular Fibroblast Metabolism
Riley J. Williams III, MD†, Erik Attia, Thomas L. Wickiewicz, MD and Jo A. Hannafin, MD, PhD
+ Author Affiliations
Laboratory for Soft Tissue Research, Sports Medicine & Shoulder Service, Hospital for Special Surgery, affiliated with New York Hospital, Cornell University Medical Center, New York, New York
Presented at the 24th annual meeting of the AOSSM, Vancouver, British Columbia, Canada, July 1998.
Address correspondence and reprint requests to Riley J. Williams III, MD, 535 E. 70th Street New York, NY 10021
Abstract

The pathologic mechanisms underlying fluoroquinolone-induced tendinopathy are poorly understood. The observed incidence of tendinitis and tendon rupture in patients treated with ciprofloxacin hydrochloride suggests that the fluoroquinolone antibiotics alter tendon fibroblast metabolism. The purpose of this study was to examine the effect of ciprofloxacin on fibroblast metabolism in vitro. Canine Achilles tendon, paratenon, and shoulder capsule specimens were maintained in culture with ciprofloxacin (5, 10, or 50 μg/ml). Fibroblast proliferation, collagen synthesis, proteoglycan synthesis, and matrix-degrading activity were analyzed. Incubation of Achilles tendon, Achilles paratenon, and shoulder capsule fibroblasts with ciprofloxacin resulted in a statistically significant 66% to 68% decrease in cell proliferation compared with control cells at day 3 in culture. Ciprofloxacin caused a statistically significant 36% to 48% decrease in collagen synthesis compared with controls in all fibroblast cultures. Ciprofloxacin caused a statistically significant 14% to 60% decrease in proteoglycan synthesis in all fibroblast cell lines. Compared with unstimulated control fibroblasts, culture media from Achilles tendon, paratenon, and shoulder capsule cells that were exposed to ciprofloxacin demonstrated statistically significant increases in matrix-degrading proteolytic activity after 72 hours in culture. This study demonstrates that ciprofloxacin stimulates matrix-degrading protease activity from fibroblasts and that it exerts an inhibitory effect on fibroblast metabolism. The increase in protease activity and the inhibition of both cell proliferation and the synthesis of matrix ground substance may contribute to the clinically described tendinopathies associated with ciprofloxacin therapy.
Footnotes

Winner of the 1998 O’Donoghue Sports Injury Research Award
No author or related institution has received any financial benefit from research in this study.
American Orthopaedic Society for Sports Medicine

Anonymous said...

My life has been ruined. I was prescribed for a soar throat and three days later began suffering excruciating tendinitis - which I had never experienced before in my life. A year and three months later, I still have tendinitis flares that leave me crippled for days. I am only 55 years old and feel like I am 80.

And I don't know what studies you are reading but the people adversely affected is in the thousands and thousands - not hundreds.

Caved in? You mean, finally did the responsible thing after so many have suffered. You are a pompous, insensitive windbag.

Anonymous said...

Please keep in mind that the incidence of drug interactions can be genetically determined, as it is for variations in the MDR gene. Hence, the incidence of interactions may be low among a large group, but 100% among a small, genetically determined group. Until these sorts of data are fully plied, it would be wise for everyone to put their guns down.

salley said...

Add me to the list of victims of Cipro. Eight months ago my doctor prescribed Cipro for a possible sinus infection. Three days into treatment my left knee became extremely sore. I stopped the drug immediately, but 2 days later while watching television a tendon ruptured in that knee. Of course my doctor said that the Cipro was not responsible. Unfortunately, my COBRA coverage had expired, and I did not have the money to see an ortho doc. After three months of much pain and using crutches, I had no choice but to sell my vehicle to get the money for surgery. The person who bought my vehicle asked me why I was on crutches, and I told him about the Cipro. He became wide eyed and said, "OMG, are you kidding me? Last year while taking Cipro my achilles tendon ruptured out of the blue. I didn't do anything to it, it just ruptured. I asked my doctor if the Cipro could have caused it, and he said absolutely not. I trusted what he told me, but I could never figure out why it would rupture like that without any kind of injury".

Dr. Mintz, this drug is absolutely dangerous, and if this happened to both me and the person who bought my vehicle, how many more unknown and uncounted victims do you think are out there?

Tilman said...

You are right, Dr. Mintz, that all antibitics have side effects. But there are severe effects and not so severe effects. "Severe" must not mean "ending with sudden death" etc. The product description offers a rankíng basing on the probability, a side effect will happen. As well, a ranking were possible basing on the severity of specific side effects.

See also http://www.levofloxacin.eu

Anonymous said...

I was made aware that there was a risk of tendon damage associated with taking Levaquin but my understanding was that avoidance of strenuous exercise was all that was needed. I did nothing but walk around the house wearing a good pair of tennis shoes and still after 6 days on the drug managed to slightly tear my achilles on both legs enough to cause drainage to the bottom of my ankle and foot.
I take no other drugs but the occasional advil and am in good health. I was extremely depressed upon hearing that I remain at risk for several more months. There should be more studies done and a much more serious warning about this risk.

Anonymous said...

Diagnosed with UTI, I was prescribed Cipro. Three days later I experienced chest pain,palpatations, headache and an over all bad feeling. The next morning I was broken out with hives, rash, stinging and itching from the top of my head to my waist. I stopped the Cipro and started taking Benedryl. I wasn't better the next day so I called my doctors office and spoke with the nurse. She said stop the Cipro and start Benadryl and pick up my prescription for Kelflex. Which I did. The benadryl made me very sleepy, therefore I was very inactive for the next couple of days. The next morning I woke up with two swollen, tight, painful knees. Still giving the benadryl a chance to help without success. I again called my doctor's office and spoke with the nurse. I told her I still had the rash and stinging, but now both knees were swollen and painful. I was unable to get an appointment and she said if I got worse to go to the ER. I already had an appointment to check the UTI two days later.
When I got to see the doctor, I showed her my knees and she said I should never take Cipro again. She gave me a dacadron shot and prescript for Medrodose pack. She told the nurse I had a rare reaction to Cipro. She also said she had one other lady who everytime she takes Levaquin she complains with her knees hurting and they had not made the connection. But, she said my knees were much worse. I'm praying this is temporary!!

michael fudge said...

well i posted something in april 2009 and here we are around 3 years later, my foot is no better, well a little maybe, but i still cant walk around barefoot, or decide to maybe have a foot race with my son, my life has been altered forever and i have learned to live with it. I wonder how it would be if i never ever.

Tina C. said...

The FDA needs a better system to track adverse reactions. Dr. Mintz cites a figure of about 200+ reported adverse reactions to quinolones. That number is likely "ridiculously" higher due to how inaccurate and outdated the FDA Adverse Events Reporting System (AERS)is.

In a day and age in which one can track one another via smart phone or quickly pull up the location of the nearest drug store by clicking on an icon, it's beyond nuts that we're still using such an antiquated database system.

We can only hope that in the near future, as more doctors convert to electronic medical records, that a more efficient means of reporting and tracking adverse reactions can be established.

Ed. said...

I have not been able to report my adverse reaction, and my physician didn't bother too. The statistics you see for this drug are not correct. Because the effects are delayed and not immediate, many people will never make the connection to their new health problems.

The number of comments in this blog in response, gives you an idea of how many people are actually adversely affected by these antibiotics.

Even after the black-box warning these antibiotics are over-prescribed and viewed as safe drugs. I was prescribed this drug for a suspected minor infection "500mg X 2 a day". The tests from the lab came back negative for a bacterial infection. And yet, the family doctor I went to gave me this dangerous drug with no warning of what could happen. Now reading about it, I realize I was given a dosage for a severe infection.

I am suffering the effects of this drug, and their so-called "tendinitis" is a huge understatement for the devastation this causes to one's body. Tendinitis goes away, this tendinopathy doesn't. I'm only 27 years old and I'm having all sorts of tendon, and nerve problems that were never there before taking CIPRO.

People should be scared when given fluoroquinolone antibiotics! They should be! I don't think anyone could ever consider potential chronic tendon problems with possible tendon ruputures in their future as a fair trade-off for eliminating a minor infection.

Ed. said...

I have not been able to report my adverse reaction, and my physician didn't bother too. The statistics you see for this drug are not correct. Because the effects are delayed and not immediate, many people will never make the connection to their new health problems.

The number of comments in this blog in response, gives you an idea of how many people are actually adversely affected by these antibiotics.

Even after the black-box warning these antibiotics are over-prescribed and viewed as safe drugs. I was prescribed this drug for a suspected minor infection "500mg X 2 a day". The tests from the lab came back negative for a bacterial infection. And yet, the family doctor I went to gave me this dangerous drug with no warning of what could happen. Now reading about it, I realize I was given a dosage for a severe infection.

I am suffering the effects of this drug, and their so-called "tendinitis" is a huge understatement for the devastation this causes to one's body. Tendinitis goes away, this tendinopathy doesn't. I'm only 27 years old and I'm having all sorts of tendon, and nerve problems that were never there before taking CIPRO.

People should be scared when given fluoroquinolone antibiotics! They should be! I don't think anyone could ever consider potential chronic tendon problems with possible tendon ruputures in their future as a fair trade-off for eliminating a minor infection.

Anonymous said...

I'm currently taking cipro right now, 7 days and previously 7 days of doxycycline to manage a uti as they were waiting on my test results. 2 pills left and I'm not peeing blood anymore, so that I'm thankful for! I'm going back to doing P90X after this, and yes I'm corticosterioids for allergies. This article has just made me more cautious, I'll keep it in mind as I workout. I have a lot of antibiotic allergies and these 2 classes of drugs are the only ones I can take. Even if something does happen, I'm grateful for my doc for trying to get rid of my uti with the drugs they actually can use on me. It sucks you guys had bad experiences with this drug class, but be grateful your infection is gone, your odds just kinda stink, but those meds have helped a lot more ppl than theyve hurt.

Anonymous said...

Wow, I can't believe what I have just read. I am so disturbed by what you all have been through. I too am a healthy 47 year old who has chronic uti infections. I have developed allergies to the usual antibiotics and was proscribed Norafloxicin. Two days into the medication I woke with a sore swollen right arm. I went to the doctor who said it was tendonitis and a drug allergy. I have been seeing a physiotherapist for over three months and my arm is still not the same. I had an ichy red rash all over me and blisters around my mouth and nose. I felt tired and everything ached while on the medicine. All symptoms are better now except the tendons in my bicep and forearm, but they have improved. I am seeking acupuncture for this now. I am praying this will be the end of it. What do we do about these dangerous drugs?

Anonymous said...

Sept. 5th, 2012

I was repeatedly given Cipro...resulting in tendon,vision,and vocal chord/
with cough problems. Can anyone here tell me of a specialist that will treat Cipro allergy bad side effects? What type of doctor do you see for the altered DNA problems Cipro causes? Please help.
Thanks, Damaged in Va.

Dr. Matthew Mintz said...

@anonymous September 5th,
Truly sorry for your suffering and the effects you may have suffered from Cipro. Sadly, despite the now known dangers caused by Cipro, how these medications lead to these damages is unclear. It is not clearly DNA damage or an allergic reaction. We simply don't know. Thus, it is unlikely you will find a physician that can fix these problems. However, you should seek care for the individual problems. For example, if you are having vocal cord and cough problems, I would see a good ENT (otolaryngologist).

Anna said...

Dr. Mintz - In skimming through the comments on the issues with cipro and other drugs in that class, I happened to notice that you seem to think that Crestor is a desirable statin drug. I think you are going down the same road with that drug as you did with the fluoroquinolones. Seriously, you need to do some research on statins and the problems associated with them. The frequency of side effects might (or might not) be lower than with the antibiotics, but OTOH, for many of the people who do not suffer any ADRs, they--directly or indirectly through their insurance--are taking a hit in the pocketbook for something that is of no value to them. Statins are a huge cash cow for the pharmaceutical companies.

I hope you learned something from the discussion on the fluoroquinolones. Doctors need to become much better educated about medications and stop being so dismissive of patient complaints about their experiences on prescription drugs.

Dr. Matthew Mintz said...

@Anna,
Thank you for your comments. I think the quinolone safety issue is very different from the statin issue. The initial though behind the original post was that the FDA seemed to be caving in to Public Citizen as publically available safety data about the quinolones didn't appear to show all that much harm. In retrospect, based on the many comments on this blog from patients who were harmed, including data acquired by some from the freedome of information act, there was/is data the FDA is sitting on that caused them to correctly make this decision. In addition, quinolones are one of many classess of antibiotics. They are most commonly used to treat urinary tract and lung infections. However, there are many more effective antibiotics in other classess that work just as well.
Statins are probably the most studied class of drugs in terms of safety and efficacy. Because of the a Public Citizen request soon after Crestor was approved, the FDA did a thorough review of all its safety data on all of the statins and released a 70 page repsonse letter essentially saying that the statins have some rare and serious side effect, but on the whole are safe drugs, with Crestor being no more dangerous than any other statins. There is no question that pharmaceutical companies have made a ton of money off of statins, and because of marketing, in some cases, statins may have been over-prescribed. However, for high risk patients, statins clearly reduce heart attacks, strokes and save lives. No alternative cholesterol lowering agent (Niacin, fibrate, omega-3- fatty acids, eztimibe) can make that claim.
Thus, for statins you have a class of drugs which, though widely used, have immense amounts of public data supporting both safety and efficacy, where no other class works, and clearly improves outcomes. For quinlones, you have a paucity of public data, with likely serious side effects of which many alternatives without those side effects are avaialable.

Anonymous said...

Surprised to see this blog article still active. I have been damaged by levaquin and cipro since 2006 and have noticed a few things over these years. Ever wonder why G. Bush had to take a few extra months off at Camp David and why he went from being an avid runner to riding a bicycle after taking Cipro during the anthrax scare? Oh, and Chaney using a crutch during the same period? And the thousands of postal workers that filled the class action suit. Rare, eh?

The FDA is the most corrupt government agency there is. Just review the Cipro NDA (new drug application). Can you imagine them going back through this paper to take out information as "redundant", why bother? Truth is I saw the information on those pages before they were edited. They listed over 50 adverse reactions, some as low as .5% which is still far higher than your 1/100,000 for tendon rupture (the NDA lists tendon rupture at 2% but who bothers to read that stuff?). I'd guess they removed those tables so they don't get sued. If only a whistle blower would come forward on this.

Anonymous said...

Dr. Mintz, Do you know of another antibiotic that treats UTI pseudomonas aeruginosa. From what I can tell, Cipro is chiefly prescribed to eradicate this type of infection. My 95 yr. old dad just finished a second round of Cipro with a second UTI. I worry about him going on it again. A couple weeks after the first round he was complaining of ankle pain and when asked where it hurt would point to his achilles tendon. The doctor wasn't concerned, but I was after reading about Cipro. The second UTI -- turns out we were looking at either taking Dad to the hospital for 7 consecutive days of IV antibiotics, or going with the Cipro. We opted for Cipro, because the trips/logistics of taking my 95 yr. old Dad back and forth to hospital would be a hardship for Dad and us. But I still worry if we made the right choice. My dad isn't complaining of the achilles pain any more recently, so I am hopeful that his issues were not tendonitis/Cipro related. Thanks for your consideration of this topic and listening. --Kathy

Dr. Matthew Mintz said...

Sorry to hear about your dad. I can not give specific medical advice over a blog without knowing all the information or seeing him in person. In general, Cipro is the preferred oral agent for pseduomonas. Understand that Cipro is commonly used for UTI's which themselves are quite common, and this is the problem. A pseudomonas UTI is quite uncommon which is why in general Cipro and other quinolones shouldn't be used. In the case of a pseudomonas UTI the small risk of a tendon rupture (serious but still rare) may outweight the risk of an untreated infection or even the risk of hospitalization for IV antibiotics. With everything in medicine, there are always options. However, choosing is not always easy. There is no right answer, but it sounds like you made the right decision for you and your dad.

Anonymous said...

So has there been any updated research on why cipro affects tendons specifically? I find this intriguing as tenocytes seem to be unremarkable in their gene expression or surface markers (as in there isn't really a marker specific for tendon cells). What is is about their makeup that causes them to be targeted directly by fluoroquinolones? Or are other tissues also adversely affected? Any info is appreciated.

Connie said...

Dr. Mintz, I wrote about my husband on this subject in 2008. He passed away in Feb this year. He was 55 years old. He never recovered from the injuries he received after taking Cipro twice. His last few years of living consisted on living his life in his recliner but for the moments of going to the restroom which was a challenge of whether he would fall and injure himself while trying to accomplish that task. Go ahead, keep on telling your patients to take that stuff. Tell them how safe it is. If they end up like my husband, you can always pass the buck like everyone else does.

Dr. Matthew Mintz said...

Connie, I am very sorry to hear about your husband. If you have read my responses to this post (which is now several years old) you will see that my position has changed. I originally wrote this piece because I was concerned that the FDA was caving to Public Citizen. They are often over zealous against the drug companies. They recommend not taking any non-generic medication until its been on the market for seven years. They were wrong about Crestor, which now appears to be one of the safest statins on the market.
More importantly, the FDA made this warning without publishing any of its own data. This makes it incredibly difficult for physicians and patients to make an informed decision.
However, in this case Public Citizen appears to be correct. It is quite possible that the FDA has not released data, because if it did, there would be so many reports of tendon ruptures for many years that they would get a lot of heat for not posting this warning sooner.
So many people have responded to this post with horror stories about tendon rupture. I am not that popular of a blogger, so I imagine that if there are so many stories like yours just here, there must be many, many more out there now.

Elisabeth S. said...

Part 1
Dr. Mintz, I hope all of the comments you have received over the past four years have shown you just how dangerous this class of antibiotics is. I believe everyone who takes it gets damaged in some way. Whenever I come across someone with weird symptoms that can't be explained by the medical community, I ask them if they had at one point in time taken a fluoroquinolone, and just about everyone of them had.

In my case, it was the antibiotic Ciprofloxacin that destroyed my life. It made a cripple out of a previously healthy and active 32-year old woman who was prescribed it for a suspected bladder infection.

The true side effects of these antibiotics are only vaguely mentioned in the package insert, and there is absolutely no mention that these can be long term. The side effects that I am suffering from include nerve damage, rheumatoid arthritis-like and pins and needles feelings in my extremities, numbness, electro-shocks, burning and tingling sensations, sensitive and fragile skin, brain fog, loss of memory, anxiety, sensitivity to cold temperatures, phototoxicity, rashes, TMJ and hearing issues, tinnitus, dental pain, vertigo, difficulty swallowing, feelings of paralysis, and such pain in my joints, muscles and tendons that I walk around like an 82-year old woman. It causes me to suffer other physical restrictions, such as not being able to stand in place, drive for any length of time, walk for any distance or lift any objects.

It has been a little over 12 months since taking the last pill, and I am still suffering from the debilitating side effects which limit me in every aspect of my life. I have developed extreme food intolerances and cannot eat out anymore. My career has taken a blow as I can no longer work full time. I have no strength to pursue a social life and am falling into isolation. I have spent tens of thousands on alternative treatments because conventional doctors cannot find anything wrong with me and do not attribute my condition to the use of the antibiotic at all. I have talked to so many deaf ears and have had to endure insults on my mental state.

Elisabeth S. said...

Part 2
If you type the words "Fluoroquinolone Toxicity" into the internet, you will see the stories of thousands of others who are suffering as I. What has gotten me through this is a support group on Facebook. We have all experienced the same symptoms, the same disregard from the medical community. We were all previously relatively healthy American citizens. There are many more sufferers who are not on these forums - sufferers who don't know that they are suffering from this because the effects of the antibiotics are often cumulative or do not show up until after the course of antibiotics had been completed. These other sufferers often believe they have fibromyalgia, lyme disease or chronic fatigue syndrome. In my particular case it was cumulative. I was prescribed Levaquin in 2008. I suffered an immediate reaction in the form of ankle problems after only two days. I made my doctor switch me to another antibiotic and forgot about it. In the weeks that ensued I developed extreme TMJ and had to seek treatment from many medical specialists such as an HNO and a dentist and was prescribed massages and heat treatment. At the time, I didn't associate my problems with the antibiotic but rather with with the stress I was under. Looking back, I was already mildly "floxed". Then at the beginning of last year I was prescribed Ciprofloxacin for a suspected bladder infection. I spent the entire summer suffering weird effects and phantom illnesses that I again did not attribute to the antibiotic. These included interstitial cystitis which basically feels like a bladder infection and for which I was prescribed more antibiotics (eventhough no doctor could ever find any bacteria), nerve sensitivities in my extremities and an extreme intolerance of cold. However, I still led a "normal" life and wasn't yet aware that my issues had been caused by the antibiotic. Then one year ago, I was again prescribed Ciprofloxacin which proved to be the final straw which broke my back, and accumulated levels sent me into an acute stage of poisoning. The reaction was so severe and immediate, that there was no denying on my part what caused it. My medical history is proof to me that it is easy to believe you "tolerate" fluoroquinolones.

In my opinion fluoroquinolone antibiotics such as Levaquin and Ciprofloxacin should only be taken if all safer therapies fail. Take it from me and all of the others who have taken the time to comment - I lost the life I had when I swallowed the pills. My old self died then.

Dr. Mintz, little can be done those who have already been affected, but how can we get the word out to help save others? Would you be prepared to write an article summarizing the comments to be published in a medical journal? If you have already decided for yourself or for those nearest to you based on they horror stories you have heard never to take a fluoroquinolone, then it would be the least you could do.

Daniel Sheridan said...

I was prescribed Cipro by the VA Hosp. for 34 Days.While on Cipro a tendon in my right knee snapped. Immediately after my last script, my vision became blurred and I started seeing double.They were able to correct my vision with Prism lenses. 2 mths later the tendon in my right bicept ruptured. 2 mths after that the tendon in my left bicept ruptured. 4 mths. after that the tendons in my back ruptured. The lost back support lead to pinched nerves in my back which led to back surgery. I am now having to draw disability because I can no longer work. This all started approximately 4 yrs ago. I am now looking at another back surgery. I have no strength in my arms because of the ruptures and constsnt pain from tendonitis and tendonosis. I am know 58, I was a Carpenter. I am in severe pain 24 hrs. a day. I am taking pain meds. which are no longer are effective. I am no longer looking forward to the Golden Years.

Anonymous said...

It is completely beyond my understanding, why CIPRO has not been withdrawn from the market years ago. CIPRO should be the drug of absolutely last resort. My own horrible experience from CIPRO is from a single dose of 500mg. I was given a 10 days course of (2x500mg a day) for a middle ear infection. After having swallowed a 500mg pill, I felt a strange tingling in my left achilles within 2 hours. I read the inlet and noticed that achilles tendonitis was reported as a rare side effect (1 in 10.000). The following 3 weeks my left achilles was very painful and sore. The pain has now slowly subsided to an acceptable level, where I can begin to walk again with minimal pain, but needless to say that this experience scared the living daylights out of me.
This is the first prescription drug that has caused me a serious side effect in my 42 years of age. The question remains: Am I really just unlucky to be that 1 in 10.000? Hardly! I can't imagine how much suffering I would have needed to go through, had I taken the remaining 19 pills of that 10 days course. The remaining 19 pills ought to be buried in Yucca Mountains along with toxic nuclear waste. UNBELIEVEABLE!!!

Anonymous said...

Another one bites the Fluoroquinolone Dust, RIP Dick Decent of the legendary band Def Leppard ~~ HOW MANY MORE MUST BE CRIPPLED, MAIMED... HOW MANY MORE MUST DIE??!


Decent had been living with the side effects from the drug Ciprofloaxin and Ofloxacin for the last few years which he had taken for an illness. He wrote at length about the drugs 2-1/2 years ago in his blog.

"My own Floxing started on Nov.13/09 and didn’t finish until Jan.12/10.
I am too ill and in shock to post any more right now, but if you take anything away from this post, let it be an insistence on NOT TAKING ANY FLUOROQUINOLONE ANTIBIOTICS…. EVER… for ANY REASON."

Shells said...

Yet another VICTIM of this horrible crime!!

"Roscoe’s BBQ shut its doors last month, when co-owner Will Moore became afflicted with Stevens-Johnson Syndrome; a rare and painful skin disorder."

"RARE"??!! Really??!! So "rare" that Levaquin now carries a Black-Box Warning for SJS??!!

Did the FDA "cave" for that one too??

Perhaps we should ask it's latest victim.....


http://www.kdrv.com/roscoes-owner-battles-skin-disorder/#comment-5325

Anonymous said...

My life was ruined at age 33 when I took a 10 day course of levaquin. I am now 37 and trying to figure out how to live out the rest of my life in this weakened, wobbly, useless condition. To me perfectly honest, the idea of a long life terrifies me. On most days, I just wish a bus would hit me and put me out of my misery.

The worst part of all of this has been the refusal by doctors to help me, because that would, in their minds, be an admission that a drug that they have prescribed countless times to countless patients might be dangerous. I don't want to sue anyone, I just want help. Why won't anyone help me?

Dr. Matthew Mintz said...

Very sorry to hear about your condition. You are likely correct that certain doctors may not seem to be willing to help because they don't accept that quinolones can cause these conditions. However, there are plenty of physicians that can help you. While it may not be possible to reverse these effects completely, a good doctor would focus on what symptoms you are having and prescribe a course of action to improve them. While we can't fix everything and we don't always understand why patients are sick, there are always options to improve a patient's situation.
If you can let me know more specifics about your condition and your general location (closest city you live near) I might be able to provide a name of someone who can help.

Laura Prince said...

Wow, interesting to see that this thread is still active. I got on the net tonight after talking to a postal worker that received Cipro after working on the same anthrax-tainted machines that caused the death of two fellow workers. She reported having a tendon "pop" in her ankle, and I wondered if I was remembering the relationship between Cipro and tendon tears correctly. Guess so! For my own part, Cipro saved my life as a young woman with a serious kidney infection. I've been prescribed Cipro on at least two other occasions and recall no adverse events. If there is a next time on a bladder infection though, I know what I'm going to say: "It's ok Doc, take a couple of days and run a culture. That way we'll know the right antibiotic to use." The thing is, doctors want to resolve your problems the quickest way possible. They don't want to be accused of delaying or withholding treatment. They worry about patient compliance. The result is often that the doctor reaches for a broader-spectrum drug- like Cipro- rather than a milder but more specific treatment. They assume we want our treatment fast and on-the-spot. They may need some reassurance that we as patients have weighed the risks, and, if the condition isn't life-threatening, are willing to defer treatment until an assessment can be made of the specific pathogens involved. It may take longer, but sounds safer given the stories I've read here!

Anonymous said...

Amen!!!! Ditto!!!! Agree!!!!!

Anonymous said...

It wasn't until AFTER my second dis tally biceps tendon rupture that I finally linked it to the Cipro.whe I questioned it with my urologist, he and his nurse nearly laughed at the idea and even argued with me over the existence of the boxed warning for such events. His nurse arrogantly whipped out her smart phone and punched in the drug name in an effort to prove me wrong. The look on her Anne the doctor's face was priceless as she sheepishly showed him the results. Even the little bit of warning given by the black box was not enough to prevent me from suffering from a SECOND tendon rupture and permanent ringing in my ears and peripheral neuropathy caused by the use of cipro. Because so few doctors are aware, my guess is that the true numbers of adverse events related to the quinolone antibiotics is grossly under reported, since they probably fail to connect the dots. The continued arrogance and closed minds in the medical bureaucracy are to blame. It seems that "do no harm" has long ago been replaced by "profit first and worry about consequences later."

UCSD Fluoroquinolone Effects Study said...

UCSD Fluoroquinolone Effects Study

Have you taken an antibiotic such as Cipro (ciprofloxacin), Levaquin (levofloxacin), or Avelox (moxifloxacin)? Would you be willing to help in a survey-based medical research study?

Dr. Beatrice A. Golomb and her colleagues at the University of California, San Diego are conducting a new study to identify and describe side effects and risk factors for good and bad outcomes involving antibiotics in the fluoroquinolone class. Other example fluoroquinolones include Zymar (gatifloxacin), Floxin (ofloxacin), Zagam (sparfloxacin), Trovan (trovafloxacin), Tavanic, and Vigamox.

Whether you believe you have experienced side effects or you believe you have tolerated them, you are invited to participate in this voluntary study. Participants possessing English language fluency from all countries are accepted.

Study participants will be asked to complete questionnaire(s). By participating in these surveys, you can help us further understand the effects of fluoroquinolones and report findings to the medical community (including prescribing physicians) and the general public. Surveys will cover your overall health, well-being, fluoroquinolones taken, and symptoms; impacts on your life and career; and your personal story.

For those without side effects, there is currently just one survey taking 20-30 minutes to complete.

For those having adverse effects, there are currently 3 (voluntary) questionnaires that can be done separately, each taking approximately 40-90 minutes (time varies per individual). Each survey addresses a different set of concerns related to fluoroquinolone effects. More voluntary surveys may be available in the future. Compensation for taking the surveys is not available.

If there is a chance you are interested in participating, please visit our website at:

http://www.fqstudy.info

for further information on this important study.

If you know of anyone else who might consider participating, then please pass on our website address. We truly appreciate your participation and referrals.

-The UCSD Fluoroquinolone Effects Study

Anonymous said...

"While it may not be possible to reverse these effects completely, a good doctor would focus on what symptoms you are having and prescribe a course of action to improve them. While we can't fix everything and we don't always understand why patients are sick, there are always options to improve a patient's situation."

I just had a humiliating discussion with my PCP where I asked him to help treat my fluoroquinolone-induced symptoms, and received the following reply: "I can't treat your symptoms if I don't know why you have them." So what does a patient do in this case? SSwitching doctors doesn't seem to be the solution because this is not the first time I have been rejected by a PCP, nor the second or third time, either.

Why does the medical community not do anything to help us?

Anonymous said...

This article published in 2008 makes me sick. You are so typical of the ignorant medical community all around us. A community that is unreliable and narrow minded. Based solely on treatment and not prevention. Financially driven rather than care driven. Patients are forced to diagnose and treat their own conditions in order to avoid receiving incompetent care that will most likely cause additional damage. And when damage does occur, the medical community turns a blind eye or writes another prescription. Shame on you for ever publishing this article! I'd hate to be your patient.

Lisa Bloomquist said...

The vitriol in most of the comments echos my sentiments, so I'll hold back.

I did see that you're interested in diabetes. Here is an article about how fluoroquinolones increase the risk of type 2 diabetes -

http://www.medical-hypotheses.com/article/S0306-9877(14)00217-5/fulltext

Here is what the FDA says about fluoroquinolones and dysglycemia issues -

"Gatifloxacin (a fluoroquinolone antibiotic) was withdrawn from the market in 2006 because of severe glucose disturbances. Hyperglycemia has also been associated with peripheral neuropathy. An in vitro study found that high glucose resulted in excessive ROS and mitochondrial dysfunction, which resulted in a high frequency of Schwann cell apoptosis. Intermittent high glucose also produced a significantly higher percentage of oxidative stress and apoptosis in Schwann cells than constant high glucose. A study done in type 2 diabetic mice saw that with an increase in extracellular glucose, there was excessive mitochondrial fission; this was thought to result in dorsal root ganglia (DRG) neuron oxidative stress and neuronal injury, or activation of the caspase cascade, leading to programmed cell death. Another study saw damaged mitochondria within 1-2 hours of exposure to elevated glucose." Page 25 of this report - https://drive.google.com/file/d/0BzLMHZg5q0Y3VkVJUmhxSlQtbWs/edit?usp=sharing

You might want to read up on this topic.