Friday, May 13, 2016

Update on Cipro

I initially started this blog as way to communicate information to patients concerned about certain medical topics, specifically those that hit the media.  With our 24/7 news cycle, multiple TV and cable channels, as well as blogs, social media, etc. there is always some new study or finding about a disease or drug.  However, patients or family members with that disease or who take that drug are often confused, because reporting on these topics tends to be confusing.  
Unfortunately, with new job responsibilities over the past several years, I have been unable to keep up with this blog.  While I have greatly enjoyed sharing information with patients, it takes a tremendous amount of time to write the type of posts on this blog, which cite multiple sources and attempt to interpret data.
However, despite not writing posts for three years, I have kept the blog active on the web.  I still get many hits, so I assume the information is still useful to some.  I continue to get inquires about popular topics.  In addition, for some posts, patients have used my blog as a forum to share experiences.
By far, the most popular post on my blog was written in July of 2008, called Tendon rupture with Cipro? FDA caves to Public Citizen.  The post has 163 comments and has over 46,000 views. Clearly, I stumbled on to something with this post.

The initial post was in response to media reports about a boxed warning placed on Cipro and other flouroquinolone antibiotics by the FDA in response to a letter by watchdog group Public Citizen.  My opinion at the time was that while Cipro was probably overused, the safety data from Public Citizen's report was actually not so bad, and came from a flawed event reporting system. Thus, I felt that the FDA was probably "caving" to public pressure. I saw this as a problem because there are many examples of FDA "warnings" that scare patients and the public unnecessarily, as well as lead to TV commercials from lawyers that scare patients from taking almost any treatment.    Most importantly, I stated that "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."  As a physician, it is hard to make decisions without looking at the data.  I thought it wasn't very responsible of the FDA to make such a warning without releasing any data.

The response to this post was overwhelming.  Patient after patient, commented on my post with horror story after horror story about problems they had with Cipro.  While this contrasted my experience with patients I had prescribed Cipro to, the sheer volume of posts told me that there really must be more to this flouroquinolone issue.  One affected patient who responded to my post actually obtained some of the aforementioned FDA "new" data through the Freedom of Information Act. He shared some of this data with me, confirming my suspicion.  Thus, I reversed my opinion.  Cipro is clearly not the safe drug I thought it was.  I stopped prescribing it for my patients, and I had indicated my position change in comments section of the post.  (I probably should have written a new post, since I would occasionally get angry responses to the original post and would need to indicate that the post was old and my position had changed).

Finally, yesterday, three years later after the boxed warning, the FDA states that these drugs are indeed dangerous.  Specifically, " The U.S. Food and Drug Administration is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options."  While it again would have been nice for the FDA to present more of the data (which was discussed in a meeting back in November, which eventually led to this announcement), I am glad to see that the FDA continued to pursue the issue and has communicated this issue to the public.

I want to thank all of the respondents to my original post who correctly challenged my viewpoint.  In doing so, you:
1. Changed my opinion and my practice.  While I never prescribed a lot of quinolones before, by stopping their use, I am sure I spared someone potentially dangerous side effects.
2. You created a forum for patients to share their stories
3. You kept the conversation going and my have helped keep pressure on the FDA to continue to focus on this issue.

I do hope that my schedule allows me to blog again in the future.






11 comments:

Anonymous said...

Thank-you for leaving the original post up, I was ready to add an angry comment myself until I read the whole thing; now I am only impressed. I applaud you for continuing to learn about issues and helping to educate others.

Tim said...

Thank you Dr. Mintz. I remember the original Fluoroquinolone blog entry on here and the exchange of (some angry) responses on FQ Toxicity. I believe I wrote one or two of them myself. I spoke at that FDA hearing, and met with Senators and staffers in DC the year before that to discuss FQ Toxicity and the blind denial of it in medicine. It means a lot to the Fluoroquinolone Toxicity support community to be heard and acknowledged by the medical community . . . finally. Thank you for returning to revisit this blog after a 3 year hiatus to acknowledge us. With much appreciation . .

Anonymous said...

Thank you Dr. Mintz. I remember the original Fluoroquinolone blog entry on here and the exchange of (some angry) responses on FQ Toxicity. I believe I wrote one or two of them myself. I spoke at that FDA hearing, and met with Senators and staffers in DC the year before that to discuss FQ Toxicity and the blind denial of it in medicine. It means a lot to the Fluoroquinolone Toxicity support community to be heard and acknowledged by the medical community . . . finally. Thank you for returning to revisit this blog after a 3 year hiatus to acknowledge us. With much appreciation . .

Donna R., RN said...

Thank you. As a RN of 30 years, I may not have believed the destruction these drugs are capable of had I not witnessed it firsthand with my father. Immediately upon finishing up a ciprofloxacin prescription, he developed severe insomnia, anxiety, leg pain, shoulder pain, vision problems, a 50 pound weight loss, tinnitus, profound neuropathy and a host of other medical issues all well-documented and unexpected with his prior decent health status. Over the next 3 years, pulmonary embolism, extensive lower leg DVT, cardiac arrythmias, renal dysfunction, severe skin rashes and breakdown, muscle atrophy, double digit tendon tears (confirmed on ultrasound), multiple new allergies, teeth falling out, more severe CNS issues, veins bulging in his legs - again all documented/treated. His physicians and specialists were at a loss. My dad was given ever-changing autoimmune diagnoses. "We don't know why this happens....." It took many months until a bright young intern suggested a cipro reaction. Searching online for cipro's side effects revealed thousands of others out there with similar, sometimes identical stories. I was shocked.

I'd given these drugs before to patients and never saw this, or did I? The ugly effects of fluoroquinolones are atypical of our perceived notions of unwanted drug reactions. They often don't appear until weeks to months to years after drug cessation. When they do coincide with drug use, simply stopping the offending drug in no way guarantees the bad effects will go away. Who on earth correlates a rheumatoid arthritis diagnosis in June with an antibiotic they took last fall? Due to the oft delayed symptoms, physicians are reluctant to associate them with a drug prescribed way back in time, even when the patient presents with a stack of literature showing it DOES happen. We have an epidemic of autoimmune disorders happening right now. The top-selling drugs in the United States are the biologics used to treat them. This explosion has a profound correlation with increased use of fluoroquinolones.

The known tendon issues mentioned in the boxed warning of the prescribing information are just the tip of the iceberg. There isn't a system in the body that can't be ruined for life by these drugs. Do the research. This IS NOT rare. Incredibly under-recognized. Grossly misdiagnosed. Denied. But not rare. You ask for more data, Dr. Mintz. Where would you like this data to come from? Bayer? J&J? Our government who gave these drugs to thousands in the military, thousands in the public during the 2001 anthrax attacks? The government who has Levaquin and Cipro stockpiled in every city across America ready for a bioterror attack? You see, the people who have the resources and credibility to get the data all have much to lose with unfavorable results. For now, it will be the advocates/respondents you thanked above who provide the data. Without them, this new warning would never have happened. Nor any other of the previous warnings in years past. These are the most determined, supportive and hard working people I've ever met. This warning is a beginning. There's so much more to do. The lives they've saved .....

I'm thrilled that you listened and will no longer use these drugs. That's so encouraging to read. Unfortunately, many of your peers will continue to use them unfazed by this new warning. Quinolones are easy, cheap, oral and effective. Known or unknown, they pretty much guarantee more business down the road. This likely will never change until a newer, equally efficacious, economical and safer antibiotic takes their place. Too late for my father. After 3 years of unimaginable suffering, he had a gruesome death one year ago caused by ciprofloxacin toxicity. It was all so preventable. So very unnecessary. RIP Daddy.

Cassie said...

In 2012 I was prescribed Cipro. No way would I have ever believed the outcome and especially that the one stupid pill I took could hurt me so bad. If someone else had told me that, I'd have probably been like some of the other people I've met, in disbelief. It's impossible to fathem the amount of pain it put me in or describe my pain in details that could be felt, but it was so bad that I had to have an MRI on my knee the following day, which cost us over $400 after insurance. Doctors have told me repeatedly it wasn't the Cipro, but unfortunately their simply saying that can't change the facts to fit their response. I was there! I have kept all of my records. I'm not a hypochondriac and rarely see the doctor more than once a year for my annual thyroid test. I was physically fit and in perfect health, minus a stomach pain that wound up being diagnosed as IBS, taking Cipro "just in case" it might be diverticulitis at 34. It was a very huge mistake on my part, that has caused me to fear all prescription drugs. I still have joint, muscle and tendon pain four years later that can't be cured. It moves around and comes in flares. Sometimes remitting for a while, only to come back. I'm not sure it'll ever go away permanently, but I continue to work and am gratefully doing way better than most who've taken this class of drugs. Thank you for your coverage on the FDA's new warnings. I'm glad others might be saved going through the same.

DD said...

I will not go into the life altering hell I have entered. For some strange reason most of the personnel in the Medical Field think they are smarter than their clients because of their education and we trusted them to be. However I think no one knows your body better than yourself. You continuously go begging for help, just to be ignored and labeled. This validation comes to late for quite a large number of us. You being a medical Professional could help in regards to this problem. For some odd reason I do believe your colleagues would take your word over that of a patient. So if you don't mind and are a serious Medical Professional you could do great deeds other than in your office. Thanks for your time.

Betsy said...

In February of 2007 I was rx'd cipro for sinusitis. I took four pills and stopped after suffering a severe reaction. It didn't end there however. My health continued to decline. I've had 3 hip surgeries and a rotator cuff tear. I've suffered neurological damage, live with chronic pain and so many health issues I could write a book. I went from active and healthy to housebound and disabled in my 40's!!! My three children lost the mother they knew. Thank you for admitting that these medications can and do cause permanent harm. I'm living proof.

Pollyanna Hopes said...

Thank you for your courage. I hope you continue to spread the word amoung your fellow physicians. I am sending a Dear Colleague letter included in the material sent to the FDA Advisory Hearing last Nov 5, 2015. This physician has been very vocal since the announcement last week. Feel free to contact me if you'd like to speak to him.

Dear Colleague:

I am writing this letter to describe my journey as a physician in understanding the potential devastating and life altering side effects of Fluoroquinolones on patients. I am a practicing ENT physician in Florida. My training included Medical School at the University of Florida where I was Alpha Omega Alpha and graduated 10th in my class. Residency training as an Ear, Nose, Throat and Head and Neck surgeon was completed at the University of Florida.

During my career as a physician in private practice I have prescribed oral Levaquin, Avelox and Cipro for over 20 years. Usually this was given for chronic sinusitis.
My wife was given oral Levaquin twice, Avelox once and then Factive over a four year period of time. Her first Levaquin precipitated peripheral neuropathy in August 2008. She had persistent and then worsening symptoms since that first injury seven years ago. In retrospect she suffered acute onset connective tissue symptomatology, severe neurocognitive injury, marked prolonged fatigue and peripheral neuropathy related to taking these antibiotics. The onset of these side effects varied from acute, within a few days of beginning the drug to later onset. To this day she suffers ongoing peripheral neuropathy, neurocognitive difficulty and persistent fatigue with joint and back pain, also visual change and thyroid dysfunction. Her life has been permanently altered. I consider myself a good physician but I was unable to recognize these injuries as arising from the Fluoroquinolones because I was not looking for these drugs as the culprit. The differential diagnosis was complicated. Now I realize these medications as the direct cause and effect.

As I realized the potential side effects of Fluoroquinolones I began looking for this in my patients. In my experience over the last two to three years three patients come to mind. One who experienced acute significant vertigo lasting almost three months from the use of oral Levaquin. A second patient with acute onset severe debilitating lower extremity pain from oral Levaquin caused him to be unable to work as a truck driver for two months. A third patient is a 23 year old girl given oral Levaquin by her primary care physician for sinusitis. She immediately experienced severe ankle and foot pain within a few days of taking oral Levaquin. This patient worked as a horse trainer and rode horses daily. She quickly became unable to do her job because of severe ankle pain as she tried to place her feet in the stirrups as she rode. The patient was referred to me because of persistent sinusitis. This was cleared with the use of other antibiotics. My young patient had persistent ongoing debilitating ankle and lower extremity pain and was unable to continue in the work she enjoyed. This was noted at her last visit with me to be persistent six months after discontinuing the Levaquin. More details concerning these patients are available if you would like to discuss them with me.


This is anecdotal but caused me to review other information and studies of the potential side effects of Fluoroquinolones. In my experience I conclude these are dangerous and potentially life altering medications and should only be used in life threatening situations. The most important adage I learned as a young medical student was “First do no harm”, a very valuable basic principle for any physician. It is my belief and experience that the over prescribing of these antibiotics violates this basic principle of medicine. I no longer prescribe Fluoroquinolones to my patients. I will be happy to discuss my experience at any time.

Sincerely,
Lawrence W. Rodgers, Jr. MD
Otolaryngology

Pollyanna Hopes said...

Dear Colleague:

I am writing this letter to describe my journey as a physician in understanding the potential devastating and life altering side effects of Fluoroquinolones on patients. I am a practicing ENT physician in Florida. My training included Medical School at the University of Florida where I was Alpha Omega Alpha and graduated 10th in my class. Residency training as an Ear, Nose, Throat and Head and Neck surgeon was completed at the University of Florida.

During my career as a physician in private practice I have prescribed oral Levaquin, Avelox and Cipro for over 20 years. Usually this was given for chronic sinusitis.
My wife was given oral Levaquin twice, Avelox once and then Factive over a four year period of time. Her first Levaquin precipitated peripheral neuropathy in August 2008. She had persistent and then worsening symptoms since that first injury seven years ago. In retrospect she suffered acute onset connective tissue symptomatology, severe neurocognitive injury, marked prolonged fatigue and peripheral neuropathy related to taking these antibiotics. The onset of these side effects varied from acute, within a few days of beginning the drug to later onset. To this day she suffers ongoing peripheral neuropathy, neurocognitive difficulty and persistent fatigue with joint and back pain, also visual change and thyroid dysfunction. Her life has been permanently altered. I consider myself a good physician but I was unable to recognize these injuries as arising from the Fluoroquinolones because I was not looking for these drugs as the culprit. The differential diagnosis was complicated. Now I realize these medications as the direct cause and effect.

As I realized the potential side effects of Fluoroquinolones I began looking for this in my patients. In my experience over the last two to three years three patients come to mind. One who experienced acute significant vertigo lasting almost three months from the use of oral Levaquin. A second patient with acute onset severe debilitating lower extremity pain from oral Levaquin caused him to be unable to work as a truck driver for two months. A third patient is a 23 year old girl given oral Levaquin by her primary care physician for sinusitis. She immediately experienced severe ankle and foot pain within a few days of taking oral Levaquin. This patient worked as a horse trainer and rode horses daily. She quickly became unable to do her job because of severe ankle pain as she tried to place her feet in the stirrups as she rode. The patient was referred to me because of persistent sinusitis. This was cleared with the use of other antibiotics. My young patient had persistent ongoing debilitating ankle and lower extremity pain and was unable to continue in the work she enjoyed. This was noted at her last visit with me to be persistent six months after discontinuing the Levaquin. More details concerning these patients are available if you would like to discuss them with me.


This is anecdotal but caused me to review other information and studies of the potential side effects of Fluoroquinolones. In my experience I conclude these are dangerous and potentially life altering medications and should only be used in life threatening situations. The most important adage I learned as a young medical student was “First do no harm”, a very valuable basic principle for any physician. It is my belief and experience that the over prescribing of these antibiotics violates this basic principle of medicine. I no longer prescribe Fluoroquinolones to my patients. I will be happy to discuss my experience at any time.

Sincerely,
Lawrence W. Rodgers, Jr. MD
Otolaryngology

Lee Hoffman said...

Thank you so much for writing this.. after tens of thousands of dollars, total financial devastation and possibly 1 doctor believing me that my side effects were the original cause it HAS been hell... coming closing to jumping off a bridge many times but test result keep proving the issues and progressive problems resulting in this drugs ability to destroy cells, change DNA cause neuro issues.. I turned 56 and all of the sudden bed ridden.. especially after being a workaholic .. 3 children, 6 grandchildren and unable to be a proper grandma due to pain, exhaustion and even difficulty in brain activity. Sometimes I downright seem stupid because I can't say the words in my head. When I knew it was bad was when I couldn't remember my son's name. Then it came back as if nothing was wrong for 3 weeks after taking another antibiotic and now down again.. something is awful about this, the sheer stamina these drugs have, they don't seem to stop what they were made for...killing everything in our body
I hope more docs join the truth train so less of us have to endure this new Normal
Lee

Unknown said...

Dr. Mintz, much respect for your ability to listen to patient experience. I took cipro for 9 day 3 years ago and still can't go up stairs without knee pain. I feel lucky after reading some of the other stories.

Bryan