As reported today by the Washington Post, Primatene Mist’s days are numbered. The FDA announced today that "the only over-the-counter asthma inhaler sold in the United States will no longer be available next year as part of an international agreement to stop the use of substances that damage the environment."
This is because, similar to the old albuterol meter dose inhalers, Primatene Mist uses a CFC as a propellant which is harmful to the environment. I blogged about this previously (see FDA Announces End for CFC-Propelled Inhalers Asthma inhalers and More on Asthma Inhalers ).
However, the loss of Primatene Mist is a good thing in my opinion. Primatene Mist is epinephrine. It is a bronchodilator, which is why it relieves the symptoms of asthma. However, it is quite dangerous, especially without a prescription. First, it is not just a beta 2 agonist like albuterol which works almost exclusively on beta receptors in the lungs. It also aftects beta 1 receptors in the heart and alpha receptors in the blood vessels. The primary use of epinephrine is medicine today is to give it to patients who are a risk of immediate death in order to restart their hearts. In addition, having any bronchodilator, even albuterol, over the counter, is a bad thing. We know that increased albuterol use is associated with increased ER visits, hospitalizations and even death. But at least we can monitor albuterol use, because it must be prescribed by a physician. We have no way of knowing if a patient is taking too much Primatene mist until they are dead.
Under a physician's supervision, with a proper asthma plan and additional chronic maintenance medications for asthma, such as inhaled corticosteroids, bronchodilators can be used safely and effectively. However, over-use of these medications especially in the absence of inhaled corticosteroids is dangerous. This is why I never write an albuterol prescription with any refills. If your asthma is well controlled, one albuterol inhaler should last you a year and you shouldn't need refills. If you are refilling the albuterol more than one time in a year, by the NIH's criteria, your asthma is not under control and you may need to change to a stronger daily medication (for example, switch from Singulair to an inhaled corticosteroid or ICS, or switch from an ICS to an ICS/LABA combination).
For those patients without prescription insurance who relied on the relatively low cost of OTC Primatene mist, be advised the GSK makes a sample size of Ventolin HFA (60 inhalations) that is only $9 out of pocket (regardless of insurance) at most major retail pharmacies. This will of course require a doctor's prescrition, but I believe that is a good thing for the reasons stated above.
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Writing this from a small mountain community in the West, a hour away from any kind of medical care. In the adjacent large wilderness, it is not uncommon for backpackers and horsemen to be two days away from any medical care and to have no communication capability. Some of us carry Primatine Mist inhalers in our first aid kits, even in the absence of specific known indications in anyone who is along:
http://www.wemsi.org/epinephrine.html
Would you see an OTC epinephrine inhaler as being potentially a lot better than having nothing under such circumstances, even if not optimal? Would the ability to deliver multiple doses over time in a very remote setting make it more flexible than, or perhaps a useful adjunct to an epipen?
certainly having an emergency kit in remote areas is a great idea. also, something is surely better than nothing. I am sure there is a way to get an albuterol prescription and an epi pen from a prescribing physician to ensure you kit has the most appropriate medications.
Your argument that Primatine Mist should not be OTC because it is too dangerous does not add up. I suppose you would like to take Tynenol and Asprin off the shelves as well, as these can be very dangerous if used improperly. That is, however, why they put directions on the box.
The truth is albuterols do not work for some people, while Primatine does. The major pharmaceuticals are using the CFCs as an excuse to push a small time pharm company, Armstong, out of the market. Then the consumer will be forced to come to your office where they can see your collection of Singulair branded pens, note pads, calendars, posters and wall clocks while you write them out a prescription for what else, Singular. A drug that will cost them more, give them more side effects and may not be as effective. I challenge you to throw away all of you Singulair branded products tomorrow, give back your free samples and start medicating based off of medical studies not funded by the pharmaceutical companies.
But that, in fact, is what some asthma sufferers do, relying on non-prescription Primatene Mist
"I suppose you would like to take Tynenol and Asprin off the shelves as well" Actually, this idea has merit. Tylenol and aspirin would never be approved today for OTC use and may not even be approved by the FDA using current efficacy and safety standards. In fact, the FDA is looking into taking Tylenol out of some prescription and OTC meds where it is in combination with other drugs. Though I think it is safe to leave Tylenol and aspirin on the market for now, I believe the risks of OTC primatene are far great, and because albuterol is much safer, I am happy to see it go.
"The truth is albuterols do not work for some people, while Primatine does." Actually, I am not aware of any study the shows this. Every patient responds differently, and because Primatene is more potent, patients are likely to respond a bit better. I is possible that some patients respond only to Primatene and not albuterol, but the number of patients in that category would be very, very small.
"your collection of Singulair branded pens, note pads, calendars, posters and wall clocks while you write them out a prescription for what else, Singular." Pharma stopped giving out all of these things a few years ago.
"I challenge you to throw away all of you Singulair branded products tomorrow." If you search my blog, you will see that I am not a big believer in Singulair, and rarely if ever prescribe this.
"start medicating based off of medical studies not funded by the pharmaceutical companies." Unfortunately, most therapeutic studies are funded by the industry. The government or other non-biased parties rarely do any therapeutic research. The asthma guidelines come from the NIH (goverment) but base their findings of studies that are mostly funded by the industry. The NIH guidelines state that beta 2 agonists should only be used intermittently, and use of these meds more than twice a week indicates poorly controlled asthma that increases risks for hospitalizations and death. They recommend that any patient taking rescue inhalers more than twice a week take an inhaled cortiscosteroid. I have worried that with OTC Primatene that patients would use this more than twice a week without the use of an inhaled steroid (which requires a prescription) and increase the risk of hospitalization and death.
Thus, I remain glad to see Primatene Mist go.
Same as you said. Every step to save our environment must be taken. I hope all such decesions will be implemented in all world so that the world can become a better place to live in!!
have no insurance - cannot afford to see a doctor -
primateen mist is the only help I have for chronic lung issues. what am I supposed to do now?
Ventolin HFA 60 (sample version) is available at most retail pharmacies at $9 without insurance. You will of course need a prescription to get this. Hopefully their is a retail or community clinic in your area that will see you at low cost. If not, there is always the emergency room.
hahahhaahha a a doctor...hahahahhahaaaaaaaaa that's so funny, like everyone can afford and has a doctor not to mention ability to afford prescriptions...
" I is possible that some patients respond only to Primatene and not albuterol, but the number of patients in that category would be very, very small."
In other words, screw them... and gimme the money!
most communities have free clinics where a physician can give a patient a prescription at little to no cost. In addition, ER's have to see patients regardless of their ability to pay. Primatene mist is a dangerous drug and should have never been available over the counter. Furthermore, any asthmatic should be followed by a clinician and not manage their own disease alone. This is also true of other diseases such as hypertension, cardiac disease and diabetes. I recongize it would be more convenient for patients to just go to CVS, but that is not good medicine. For patients without health insurance, there is obviously more to this than just inconvenience. However, it is still bad medicine for asthmatics to manage their disease without physician supervision.
I have a form of asthma called asphyxic asthma where i can go from normal to dead in seconds. Primatine Mist is the ONLY thing that saves me when I have one of these attacks..Without my primatine mist inhaler i would be long time dead before rescue personell could get to me . What do you propose I do besides hitting myself with an epi-pen several times daily (and yes I am prescribed epi in pen & bottle form!) or permanetly residing in a hospital for the rest of my life ?
Thank you for your medical insights. Is it possible you could give reference to actual clinical trials indicating side effects of Primatene Mist ? As I understand, epinephrine is close to actual substance produced in the body.
Clinical trials of primatene mist are so old that I am not sure they would be relevant. (Couldn't easily find a reference). The fact that epinephrine is a natural substance does not mean it is safe and without side effects. When the body makes epinephrine that's fine. What we are talking about is much higher (toxic) does of epinephrine, which can cause lots of side effects. The body makes estrogen and thyroid hormone as well, which are used as medicines. However, these medications also have side effects.
I have read Tachycardia is a common side effect of adrenaline administered subcutaneously or intravenously. But it seems inhaled adrenaline usually reduces heart rate or only slightly increases heart rate. One publication said that the potent vasoconstrictive effects of adrenaline on
the respiratory mucosa limit its systemic absorption and
consequently its ß1-adrenergic (tachycardia producing)
effects. It was reported that adrenaline reduce the inflammatory airway obstruction unlike Albuterol which has only bronchodilatory effect and significantly increases heart rate.
Is there any comparison on the relative safety of Albuterol vs Primatene Mist for mild intermittent asthma without the use of ICS ? Please advise.
I think your selfish to those of us who dont have insurance an cant afford the high dollar doctor bills.. I dont think this is a good thing for alot of people .. There will still be ways to get it so you havent stopped it .. you suck hope you cant breath ...
I am a 62 year old male that has used primatene mist sence it came onto the market. I had severe asthma in my younger years where I didn't have medication available, aside from some asthmadore, if Dr mintz knows what that is. I never had axcess to a medical doctor, just couldn't afford it. When I became a teenager a device called a nebulizer ( glass device where forced air changed the liquid medication to a vapor)came out. It worked very well and cost almost nothing. A small 2oz. bottle of medication used in this device would last for an onbelieveable amount of time. It's a shame they pulled it from the market. I've never had any side affects from primatene mist whatsoever. I've never taken more then the recomended dose at any one time but as many times a day as needed, and that at times went into the double digits. I really doubt it's anywhere near as dangerous as you suggest. My son and daughter both have asthma. They now use a doctor prescribed medication until there prescription runs out ( refills you won't won't write) and then they are back to primatene mist. It actually probably saved my spouse life one night when she had an allergic reaction to a blood pressure medication she had been taking for years. Her face swelled and she couldn't breath.
A panicked me took my primatene, (knowing it had epinephrine in it) and gave her two puffs. Within minutes her breathing became easier. Do you thing I would even slightly risk their lives if I thought primatene was risky? I noticed you saying you don't prescribe refills. I wouldn't either if I knew the ($) I was going to make from appointments and prescriptions from $80.00 a bottle drugs you prescribe. Are you sure you didn't migrate from wallstreet? Lets see ($) x how many people use primatene mist is this world. Oh yes, my nephew is a doctor.
Oct 26 Anonymous, I agree with you.
I'm a 56-year-old asthma sufferer who has pretty much used Primatene daily since the 1970s. I have NEVER been to the emergency room for asthma or (WTF) "epinephrine poisoning". I've tried the albuterols, but they're not effective at all.
I'm assuming that Dr. Mintz is not an asthma sufferer himself. I don't know what kind of patient would be at risk from inhaled epinephrine, but if there are studies or even anecdotes of people dying from Primatene abuse, I'd like to see the evidence. I don't believe it exists.
Singulair is worthless to me. I found Advair to be worthwhile in controlling my asthma, but it's incredibly expensive. Given the choice of spending $80 every month to control my asthma, or $20 every two months to manage it, I'll choose to manage it with Primatene.
Hopefully someone will bring out an epinephrine inhaler using HFA that will sell over-the-counter. I am certain that there will be many more emergency room visits and likely even deaths because this medication is no longer available than were ever caused by its purported abuse.
Your attitude is that of a clinician, not a sufferer of asthma. I wonder what all the physicians will say when the first death is reported because some person no longer had access to Primatene Mist. Shame. This will take a lawsuit to overturn. Ephedra was banned by the FDA and guess what it took a federal lawsuit to put it back on the market. Unfortunately, many will die in the meantime. I hate physicians. I had to go to the ER this summer and did not have insurance. It cost me over $2,000. How cost effective is that in the long run? Is it reasonable to send people who are having an acute asthma attack to the ER? When all they need is a few puffs on a cheap, effective inhaler. Whether the person has insurance or not, that is a waste of money.
This was nothing but a cash grab by FDA. They make up a bunch of phony claims about the competition's product, pay a bunch of crock doctors like this clown to back them up, and effectively get it removed from the market. it's all just big business. where's the tangible evidence of this particular product being harmful to the users or to the environment? The FDA has approved countless medications that leave patient in worse condition than they started. And I'm quite sure this "doctor" has prescribed just about all of them to his patients at one point or another. Why would they do this? because the pharmaceutical companies keep their pockets nice and fat in return for pushing their poisons on us, the unexpecting victim... I mean patients. Why else would they remove a product that has been effective for so many people who suffer from asthma and other breathing complications? If it was so dangerous it would've been pulled from the selves long ago. The truth of the matter is, FDA approval has absolutely nothing to do with the safety or the effectiveness of a product. It's all about $$$
I have been using primatene mist since I was 12. I am 40 now. Since that time I have tried ever medicine used because I knew the time would come for it to be off the market. Out off all the medicine, Ventolin, abeuterol, etc., nothing works like primatene mist. I have seen the docter after docter, and prescribe medicine after medicine, and still nothing works like primatene mist. By taking this off the shelves could result in a lot of death. May God be with you.
Obviously we ALL see this is a bunch of BS. We need to come together and do something to get this over turned. Primatene Mist had been my 3rd lung for omost of my life. NEVER EVER hospitalized for using it. It works better than breathing treatments for me. I wish this Dr. would have never tried to answer these questions because its like a big slap in the face. F you broke MFers is basically what the Dr.s are saying. Well you know what punks...F u 2 fraudulent faggots. Primatene Mist will make its way on the black market. The government cant stop the flow of drugs into our country but finds a way to attack its citizens with breathing problems. Cowards
I do think this drug is dangerous and should be pulled off the market. I think the use of this medication made my health worse and I seriously believe had I not of gotten off of it when I did that I would not be here to type this comment in now. I am 43 years old. I started using this medication in 2000 and continued until 2005 where I had some major problems with my health. At first it worked great but as time went on I found myself without realising it that it was taking more and more of it to control my symptoms. I didn't see any vivd warning labels and being it was over the counter I had a false sense of security in thinking it was totally safe.It started off with a higher heart rate off 110-120 bpm and increase in blood pressure that had me started on blood pressure medication. Later I went on to experience horrible stomach pain, nausea and vomiting to the point where I could not go to work. This resulted in my having a cholecystectomy done. The illness continued.I was found to have a large liver with no etiology,wound up in the hospital for a week with more GI comlications have to have a blood transfusion. One day I went to use the inhaler when my lungs felt like I had sprayed pepper spray into them.Finally I saw an old school MD that told me to get off that medication that it was killing me. I did take his advice. My lungs paid the price I now have Moderate COPD. When it comes to a drug that plays such an important roll as your Breathing and just your overall health this should be monitored by a MD.I blame myself as much as I do the drug. I didn't see a doctor as I had no health insurance so my asthma was poorly treated, but nothing in or on this medication made me know what my risks of taking it were.
Primatene availability is already near zero today on December 8 even though the Primatene box says it will be unavailable in January 2012. People who do not have the luxury of driving from store to store seeking a new one when their inhaler runs out this month are going to die. I hope the bus gets them to the ER before that happens. I also hope not too many people are ripped off by internet fraudsters claiming to sell Primatene online. Ah well, let's face facts: It's just poor people / minorities who will die in the coming weeks, right? Wrong. Rich folk, fly but forget your prescription inhaler. Good luck with that!
So now the FDA is concerned about the environment? This is so very transparent. Cigarettes are sold over the counter, are far more dangerous than a Primatine inhalor, especially to Asthma sufferers who are often forced to inhale second hand smoke.
How much did Big Pharma pay you write this article Doctor Mintz?
I've been in Primatine for years. It's the only thing that works for me. Even Singular did nothing by comparison. In seconds I can go from a bad asthma attack to breathing freely because of Primatine. I have never known anyone who has ever suffered medically due to using Primatine (unlike most of the drugs your industry irresponsibly pushes).
Doctors are about as trustworthy as mechanics and lawyers these days and what's worse, they seem to have less and less time to spend with each patient and know so very little about the drugs they push.
I have used Primatene mist since I was a child and have never been hospitalized from using it. However I have been from NOT having it. For the last 2 years, knowing they would be taking it off the market I have been trying ALL of the RX inhalers, and NOTHING has worked for me. As of today, I have written my will and instructed my family to document what happens to me as I face my upcoming death. After I am gone I want them to sue the pants off the FDA!!!! I know I am not the only one who will suffer and DIE from this decision.
Primitine mist has never hurt me but it has saved me countless times. the script inhalers all choke the life out of me, they do my dad too. Even with the bags, spacers and whatnot they still gag the hell out of me. Primitine was there to save me countless times. If there is a movement to bring it back please contact me at zoomin41@ymail.com I'll be on that train for sure. You Doctors have no damn clue what has been done with this ignorant move by the FDA and it all comes down to money. Primitine was cutting into the big pharm pockets a little too deep so they got rid of it. There will be deaths associated with this decision. I hope you pompous bastards can live with that. I am sure you can because you have no damn souls left. I have used it my entire life, I am 42 and I have never had a reaction to it what so ever other than, get this , I could get air into and out of my lungs. Take your crap drugs you push, with many more side effects and shove them A-hole.
Wow. What an arrogant and pompous article. " I won't write a refill" and "just get a a prescription" or "go the emergency room" Are you really that out of touch with the state of affairs in the US or do you just not care? An er visit cost 1000's and you best believe the hospitals come at you with both barrels if you don't pay. Even if you have insurance the copay can be 25 or 50 bucks. Then another at least 50 or so for the prescription to be filled. When a family only has maybe a couple of hundred bucks to last the two weeks until payday after paying mortgage, food, utilities going to the doctor can be out of reach even for folks with insurance. People without it forget about it. Maybe primatene mist wasn't optimal. I don't know. I do know it was a valuable to people who have very limited choices. I can tell by reading this blog post you do not Cate or understand or Mayne even care to understand. I do know that people have held the medical profession in high regard for years, and rightly so. I do think it is time we understand that doctors do not give a rip about us as patients. They care about our safety only as long as it doesn't raise their malpractice insurance past that they care about the money. Which is fine it is what it ia. Just don't come righting vs like this blog acting like you care about what is best for the patients because that is a falsehood.
Wow, Thanks to this crap I found the last store that had 2 left! I went there and was told I could get one and the Pharmacist refused to sell it to me even though they had 2 left! Now I will be out soon and will have to end up making a trip to the ER due to no insurance at the moment. It has never cause me any problems and I have high blood pressure! This is such BS! They care about the environment. Psh! What a huge scam! It's all about the money! This is rediculous! Let me tell you. I am thrilled just as much as the other people in this article! If they are so worried about the air then lets stop using cars, hair spray, people smoking... the list goes on!
"Clinical trials of primatene mist are so old that I am not sure they would be relevant." - Dr. Matthew Mintz
http://chestjournal.chestpubs.org/content/118/2/522.short
http://onlinelibrary.wiley.com/doi/10.1111/j.1610-0387.2008.06938.x/full
http://www.annallergy.org/article/S1081-1206(10)61014-9/abstract
And if you don't want to pay for the articles:
http://blogs.webmd.com/allergies-and-asthma/2006/03/primatene-mist-or-albuterol.html
Medicine may be an applied science, but it is still a science and as a scientist you must hold yourself to the same standards of accuracy as one would expect of any mathematician or physicist. In the case of medicine is it even more important than in any other field of science because your practice directly affects the quality and length of people's lives.
In other words: Do your research or quit your job.
Anonymous-
Reference #1 is an AMA consensus statement from 2000 stating "The AMA encourages the FDA to reexamine whether OTC epinephrine inhalers should be removed from the market."
Reference #2 is a German Dermatology journal (probably not a good authority on Primatene Mist) from 2008 that is focused on anaphylaxis and not asthma. They state that for anaphylaxis "Intramuscular administration of epinephrine is superior to subcutaneous administration." I would agree. Patients with anaphylaxis should use an Epi-Pen, not Primatene.
Reference #3 is a 2005 study in eight patients (don't know how this got published) showing equal efficacy of albuterol to epineprhine. (The issue with Primatene is not efficacy, but whether it is safe to use over the counter).
None of these are large, randomized trials that look at the efficacy and safety of epinephrine. Moreover, the only relevant article to OTC use of inhaled epinephrine for asthma shows the AMA suggesting the FDA consider taking off the market.
I thus stand by my original statement that Clinical trials of primatene mist are so old that I am not sure they would be relevant."
Our health care system is horrible. Unlike most countries who have universal health care, about 50 million US citizens are uninsured and many are underinsured. In addition, co-pays for prescription medications for poor patients who have insurance make it difficult for many to get their medications.
This is a situation that must be fixed. However, that does not mean that a potent and potentially dangerous medication should be used without a doctor's supervision and monitoring.
For those lacking coverage, there are a variety of solutions. Up to 50% of people elligible for Medicaid simply have not signed up. Many areas of the country have free community clinics that offer free services. Again, this does not solve the problem. However, neither does allowing Primatene mist to remain over the counter.
It makes no sense that an affordable over-the-counter asthma inhalant was pulled from the market without a replacement. I understand the decision to pull Primatene Mist happened in 2008 to comply with international CFC rules. But I urge the Obama Administration to reverse this decision until a replacement inhalant is developed. I along with perhaps thousands of other asthmatics could die because of this decision to pull Primatene Mist from the market.
Ventolin HFA 60 (sample version) is available at most retail pharmacies at $9
uhh, huuhh, right. I believe that. Really, I do. I do.
How about YOU start seeing patients at no change for asthma? If it is so cheap and easy for the patients, you should be able to cover a dozen or two without any significant problems.
RIGHT??
Here's the link for Walmart. I believe you can get ventolin for $9 at any major pharmacy.
http://walmartstores.com/pressroom/news/8887.aspx
Regarding seeing asthma patients for free, as I stated before, the lack of access to healthcare for so many in our country is horrible. However, that does not mean that it's OK to provide poor or even dangerous healthcare because of this problem. I don't think patient should manage their diabetes on their own, I don't think patients should manage their high blood pressure on their own, and I don't think patients should manage their asthma on their own.
"Actually, I am not aware of any study the shows this. Every patient responds differently, and because Primatene is more potent, patients are likely to respond a bit better. I is possible that some patients respond only to Primatene and not albuterol, but the number of patients in that category would be very, very small." Your words Doctor well guess what I'm one of that very, very small group. I guess that means I'm worthless, and it doesn't matter whether I need oxygen.
If albuterol doesn't work for you, there are several other alternatives.
I am not opposed to inhaled epinephrine in the rare cases that it is needed. What I am opposed to is Primatene being over the counter and used without consultation of a physician. If your asthma is so severe that you do not respond to albuterol, then you should be monitored by a physician regularly.
"Dangerous" = millions have used it for decades without any problems.
Why all of the animosity towards freedom? I should be able to choose without some neeby doctor in my business. That you do not think it is safe or right is irrelevant. It's not your life.
Mind your own.
My husband has now run out of his Primatene Mist Inhaler. With no insurance and no way to find Primatene, which he's taken for 25 years, he is unable to make it to work today due to his lack of oxygen!!!!!! This is the most horrible move you doctors have pulled in a long time and I agree, its all about the money!!!!!!!
I have tried everything to find just one refill...
Well here's my take:
1. Dr. Mintz means well but I'd like to see the study that shows Primatene Mist was as dangerous as he claims. Now I'm sure there are risks but, over the counter pain medications can be just as dangerous and we haven't banned them yet.
2. BEFORE we ban a product that has obviously helped many individuals we should make sure a comparable product at comparable cost is available to replace it. A sample vial of albuterol rationed out without refill is not an acceptable option.
3. The ban is simply illogical. Let's take this product off the market while we allow everything from hairspray to cigarettes to stay? Where's the study that shows asthmatics use of primatene is more harmful to the environment than the BILLIONS of automobiles in use?
SO in order to afford to take care of myself I must apply for financial aid? This is nuts...COMPLETELY NUTS!
Anonymous 1/23, you raise a few good issues. Let me clarify:
1. Danger of Primatene vs. danger of albuterol. Both are dangerous. There is clear evidence that over use of albuterol, particularly if used without an inhaled corticosteroid, leads to increased ER visits, increased hospitalization and increased death rates. There is no data to show that Primatene is any worse (mainly since it is an older drug and over the counter). However, it's at least as dangerous as albuterol. Also, because of it's lack of selectivity for the beta 2 agonists (it affects the heart and lungs, whereas albuterol affects only the lungs), it definitely has more side effects. I don't think albuterol should be over the counter, and I don't think Primatene should be over the counter. I prefer albuterol over Primatene because it has fewer side effects and is better studied. Regardless, I think both medications should be used only under a physician's supervision.
2. The logic of the CFC ban. I am not arguing that the CFC ban was logical. The amount of CFC's in inhalers is probably so small that it has limited affect on the environment. Their is no question that the drug companies who make the HFA products benefited from this, though I have no knowledge of any shady dealings.
3. Cost of health care. I can't state enough that are health care system is horrible. Every American deserves affordable health care. No American should have to decide between feeding their family and taking needed medicines. This is true regardless of whether they have high cholesterol, diabetes, high blood pressure or asthma. That said, in the same way that I don't feel any of the above conditions should be managed by a patient on their own, I similarly feel that asthma should be managed with consultation with a doctor. I feel horribly for asthmatics that used Primatene because they can not afford anything else and can not see a physician. I hope that our country can fix this situation ASAP. However, this does not justify the availability of over the counter Primatene in my opinion.
The people who claim "most communities have a free clinic" or assume that those without insurance can just blow a magic flute and jump on state-funded healthcare programs are full of more holes than the ozone that is believed to be more important than human life. The fact is, Primatene - just like herbal remedies that we KNOW work for other problems - is being pulled because it is taking MONEY out of the pockets of physicians, hospitals, and insurance companies, and when those economic giants lose money, the government loses income taxes on their high pay. Primatene is being pulled because of the propellant, with claims that it is harming the ozone, not because it is anymore dangerous to human health than the chemicals doctors prescribe and cash in on every day. The fact is, human life is not nearly as important at the lower end of the income scale, and it is naive, selfish, and rude for doctors to spout off, "Just go to the ER" or "Anyone can get a prescription" or "Find a free clinic," because these options only sound good. In real life, for those of us who cannot afford doctor visits, prescriptions, or insurance but also cannot get assistance because we have the luxury of choosing between food or healthcare for our children, this advice is about as ridiculous as telling someone they can fix their car by taking it to a car wash. Primatene was pulled because it keeps low-income people alive without the high-income doctors and Big Pharm cashing in on it. My husband has severe asthma, and eno0ugh Primatene to last maybe a month if he's lucky. In this country, one can get in legal trouble for not intervening when they see someone else being harmed. Nice that the people who pulled Primatene get some kind of buy on that, since they can now stand idly by and watch millions of Americans suffer.
Dear fellow asthma sufferers --
I encourage you to write to your congressman, senators, and the FDA: , urging them to rush approval of a new version of CCF-free Primatene Mist which is currently being developed by Armstrong Pharmaceuticals. Better yet: put the old inhaler back on the market until such time as the new one is available. People's lives may depend on it!
Like many of you, I have used Primatene Mist since it first came on the market with no ill effects. It is by far the most fast-acting and effective product I've ever used and I've pretty much tried them all.
I lost my job in August and have no health insurance. If I want to breathe, I am having to pay out of pocket for Advair ($215) and Xopenex HFA ($52) -- products with far more dangerous side effects than epinephrine.
Dr. Mintz, I thank you for providing this forum for people to express their opinions. Based on my experience of forty years of using Primatene Mist, I believe your prejudice against this product to be unfounded. The products you suggest are not very effective and the fact that you want to charge your patients for office visits every time they need a refill in addition to the high price they are already paying for the medications, says you are sadly out of touch with reality. You obviously have never known what it's like not to be able to breathe comfortably. It's too bad you can't substitute a little compassion for your arrogance and smugness related to this issue.
Meg
@Meg-
I was an asthma sufferer as a child so I do know what it is like not to breathe.
I am very sorry you lost your job and insurance coverage. Advair and Xopenex are not far more dangerous, and in fact, are likely substantially safer. In addition, if you see a physician, he or she should be able to get these medications to you for free if you have no health insurance (see each company's web site for information or email me if you can't find it).
@autiej
Since I have no knowledge of the role of those that might have benefitted from the removal of CFC's may have had in this legislation, I will not argue the point. However, even without the CFC ban, I do not think that Primatene should be over the counter. I believe that asthma, similar to other chronic diseases such has high blood pressure and diabetes, should be managed by a physician. Some diseases like heart burn and allergies are less serious, and over the counter medications taken as directed are likely OK. I do not believe asthma falls into this category. There are 4,000 deaths per year due to asthma; 200,000 hospitalizations and almost 2 million ER visits.
Also,
Assuming you still live in Tremont City, there is a free clinic about 45 minutes from your location:
Compassionate Care of Shelby County
124 N. Ohio
Sidney, Ohio
937-492-9400
They see patients who are uninsured or have no insurance.
Also, as above, if you husband needs medications, physicians there can get you most of the prescription medications for asthma for free from the drug companies that make them.
i too am or (was) a primatene mist user and am unable to use albuterol as it does not work for me , my asthma is very bad and now i will more than likely die because i now have no primatene mist inhaler by the way doc.... proventil , albuterol , ventolin are 52 dollars each with no insurance , not that it really matters because they never worked for me... thx for being part of the move to take my life Dr.
I am a respiratory therapist AND a moderate asthmatic. I have seen people die from primatene. Epi is whatw e give dead people to estart their hearts. I am sorry for those of you that cannot afford medical care or cannot get medicaid. Yet I notice everyone has access to a computer or cell.
Aside from that, it has long been known in the emdical community about the dangers of primatene mist and it should have been removed years ago. As your asthma episode increases, your carbon dioxide level goes up, eventually shutting off your respiratory drive. Epi in primatene form is often misued and hastens these effects.
Predniasone is relatively cheap and can be taken low dose daily if you cannot afford advair. One of the reasons advair gets a bad rap is because people use it as a rescue inhaler rather than the preventative it is meant to be.
I am shocked at people wailing on this dr as if it is his fault we have asthma. I am on singulair and flovent. Previously I was on theodur but after years of it raising my blood pressure I switched to the flovent. I have a ventolin inhaler which lasts me about a year as well as a nebulizer at home. My first breathing machine was concoted for me by my ex husband who used a tire inflator and gerry rigged the pressure down to a normal psi. I got hold of a nebulizer and got a RX from my dr.
Do not blame those of us lucky enough to have insurance as if it is our fault you will not go a clinic and get the $9 ventolin inhaler the dr is suggesting . Much safer. If ventolin does not work for you, you may not have true asthma. It may be COPD, it may be chronic bronchitis or another lung disease. If it is asthma and albuterol doesn't work it is because you need a better regiment o treat your disease.
I agree that this one single doctor should not be blamed for this problem, but I'd have to disagree with the fact that Primatene alone kills people. The fact is, prescribed medications are dangerous also. If they weren't, there'd be no need for warnings of side effects, and the people who publish the PDR would be out of business. The fact is, medications are chemicals, and any can be dangerous. The issue here is that we live in a world when cigarettes and alcohol, which we KNOW are directly responsible for causing disease rather than treating symptoms, can be more easily bought over the counter than medicine. The other issue is that those who are, as the good doctor put it "lucky enough" to have insurance, have a distorted and stereotypical mindset about those who can't afford it. Statements like "why do you have internet if you don't have insurance" are ridiculous and off topic. For instance, in my case, I have the internet because it is how I do my job. Contrary to popular belief among those who do not struggle, those of us who do are not always lazy or expect the government to pay our bills. What we do expect is for the government to make it possible for us to take care of ourselves, and a government that is pulling medication from the shelves when it is some people's only affordable remedy is wrong on every level. The government allows the sale of cigarettes and can ticket us for not wearing our seatbelts, but they can pull a medication simply because they say it has potentially dangerous side effects for the ozone, of all things. It makes no sense. And as far as that $9 prescription, I'd like to know where to get it. I would happily go to a clinic if I didn't have to fork out two weeks' worth of grocery money to walk in the door, and then another $60 for a one-month prescription so my husband can breathe. We both work, we don't have welfare, and while we aren't among the "lucky" ones who have insurance, we should be "lucky" enough to live in a country that cares about all of its citizens and not just the ones in the higher income tax brackets. It's simple: If remedies like Primatene exist, people do not have to pay to see doctors or line Pfizer's pockets. With Big Government, Big Medicine, and Big Pharmaceuticals working together, those of us who DARE to have the Internet while not earning six figures a year are not even granted the privilege of breathing affordably. And for the record, if I read a post like that from my physician, he wouldn't be my physician for long. I'm not sure how much more uncaring and condescending someone can sound, and there is something to be said when a doctor tasked with caring about people cannot even attempt to sound compassionate to those who need and struggle to afford medical help.
"And as far as that $9 prescription, I'd like to know where to get it. I would happily go to a clinic if I didn't have to fork out two weeks' worth of grocery money to walk in the door, and then another $60 for a one-month prescription so my husband can breathe."
Autiej, please see my abover response from 1/30 where I specifically looked up a free clinic near your likely address. You should be able to go to this clinic for free and get prescriptions for asthma/COPD medications. Assuming you get a reasonable assessment, you may need controller medications like Advair. If you don't have prescription coverage, the clinic should be able to enroll you in a program that gives you the medicine for free. (The same is true for Ventolin). If you do have prescription coverage, their are coupons that lower the price to $25 for a month supply.
If you or your husband just need a replacement for Primatene (which I doubt, since if he has severe asthma he should be on something linke Advair), Ventolin is available at CVS, Walmart, Target, RiteAid, and other major retail pharmacies for $9 (with a prescription).
America is a great country, but we have some issues. Many of our citizens go without adequate health care coverage. We also allow harmful products like cigarettes to be sold. However, this is not the point. The point is that asthma is a serious disease. It should not be managed without a doctor's supervision. If you husband truly has severe asthma, he should not be on Primatene mist. He should be on a prescription controller medication so that he doesn't need a rescue medicine like Primatene. And, if he still needs a rescue medication, he should be on something that has fewer side effects, such as Ventolin or Proventil. There is very good data that patients with severe asthma not on controller medications are at risk of worsening lung function, hospitalization and even death. Please get your husband evaluated and properly treated at a medical clinic (such as the free one I directed you to ) ASAP.
As an asthma sufferer who used primatene and now has to pay the cost, my heart, health, and lungs, please seek professional medical help. I wish I had known sooner so I could have stopped sooner. Read that label so you can realize you do not know have the words on it. All this good doctor has said to us is seek a medical professional and stop diagnosing yourselves. Good advise. Primatene worked for my grandmother, for her lung cancer... She never had asthma. Maybe its working for you because its not asthma. See a doctor. Love your family enough to find out what can work or control it. No one wants to explain to their loved ones, their kids, husband or wife, that we just don't have as much time together as normal. That my heart or lungs just won't last that Much longer. They are worth that day to travel to the free clinic, they are worth me calling or researching that rx company to see what offers they have. And most of all, you are worth it. So stop complaining and take care of it before it takrs care of you. Thank you doc for bringing this subject up. I read the article and every post. Most people are just jerks who can't read the label enough to understand what it days so let me translate... Primatene will kill you!
You obviously don't have asthma and have no idea what it is like to suddenly not be able to breath. I want you to take a coffee mixing straw and try to breath through it, then try to make your way to the nearest medical facility, it it's open,... and wait for an exam and an RX while still breathing through the mixing straw. See if you make it. The same applies if you have your ONE prescribed inhaler (they never prescribe more than one) but accidentally lost it or left it at home. Removing asthma inhalers will CAUSE more deaths and visits to the ER then reduce them. If you do not know what it is like to live with asthma, your OPINION of the situation regardless of you unsubstantiated medical explanation is irrelevant.
I appreciate the information about the clinic, but that's just the point. I have been trying to find a clinic for a very long time - not just for my husband's asthma, but also for my daughter and myself to have some kind of go-to healthcare - since we don't have insurance and simply cannot afford office call costs as well as prescription costs, further complicated by the fact that few physicians will see anyone who is uninsured and needs to make financial arrangements and payment plans. The clinic you recommended is not in my county, and they only serve people in Shelby County. They closed the clinic down in my county several years ago. Case in point, I had a wisdom tooth that severely needed extraction, and since they closed our health clinic down and clinics in other counties are reluctant to see me (because I am not on government assistance and fall just above the cusp of help because I do work), I had to go to the emergency room when I had a severe infection from my tooth. For that, they charged me nearly $400, a bill I am still very much struggling to pay bit by bit. The ER doctor scolded me for not having it treated earlier and told me, flat-out, that the infection could kill me if I didn't go have the tooth extracted. As dangerous as it was, all the ER did was give me a prescription for an antibiotic and some vicodin and a warning that I needed to see a dental surgeon right away. I realize they are not staffed with dental personnel, but I couldn't afford a $400 surgical tooth extraction or I would have had it done before I went there. When I asked if they knew of any local places I could go that would work with people financially, their answer was "No. Our health clinic closed down years ago. You'll need to see a regular dental surgeon - as quickly as possible, hopefully before this antibiotic is gone." Had it not been for the kindness of one of my clients prepaying me for a year's worth of work for him, I could have died from an abscessed tooth because there are no clinics in my area and no doctors who are willing to work with anyone financially. It is not that I want FREE healthcare because I believe there are far too many people in this country who could work and will not and expect to be taken care of without putting any effort in. Rather, it is that I need it to be affordable to those of us who do work but are barely making ends meet. I live at the level where that 45-minute drive you mentioned to the clinic (who won't see my husband anyway) could be an issue because of the gas to get there, and there are a lot of people out here like my family who really do struggle each and every day just to put food on the table, even though we are working full-time and even sometimes more hours than that. For that reason, Primatene was a solution we could afford; albeit not the perfect solution, but at least a doable one. There are not enough clinics and doctors for those of us who need financial patience, and for that reason, helps that we can buy without having to pay office visit costs and occasionally heavy prescription costs are the lesser of the evils. Of course there are risks with Primatene, just as there are will all medications, but it's far riskier to allow asthmatics' very ability to breathe become dependent on their ability to pay office and prescription costs that they simply cannot pay. In any case, there is no sense beating a dead horse (I wonder if the horse had insurance?). Again, you win, Big Medicine, Big Pharmacy, and Big Government. Way to weed out those who have less income to pay taxes on...
@autiej
Again, I completely agree with you that our country should provide comprehensive care for all of our citizens. It is horrible that we don't.
This; however, in my opinion, does not justify asthmatics self-managing their asthma. I think it is far too dangerous.
There are alternatives for those without coverage. Are they enough?
Absolutely not! But they exist and are far better than practicing medicine without a medical degree.
The Rocking Horse Community center is located in Springfield, is much closer to you, and you shouldn't be limited by your residence. I strongly urge you and your family to get proper medical care there.
If for some reason that doesn't work, I spoke with a wonderful colleague of mine in Bowling Green, OH who has agreed to see you for free. I realize that this is about a 2 hour drive, but I am willing to pay for the gas. If you are interested in this option, email me directly at drmintz@gmail.com
Wow,this dr.is at least letting this blog run, Iam from Canada and have been using Primatene since I was 10 Iam now 53, Ive used it on average twice a week, I get asthma from sports to cutting the lawn to dust and have tried Ventalin etc. works but not like Primatene,I hope theres a replacement soon.,Like one person stated, its like breathing through a coffee straw !!! We need a replacement please....
Hi Sir,
While I understand the medical professions stance on OTC drugs being dangerous I don't fully agree with OTC inhalers being gone forever. I do have to say that I use Albuterol, which is very effective.
The problem I have is getting a prescription refill in time. I use the VA and sometimes I won't be seen for months, sometimes I run out before I can get seen again due to the large ratio of patients to the understaffed VA clinic. A lot of times I have to rely on OTC inhalers to get by and since the visits & prescriptions aren't free, it can be hard on my family & I financially sometimes. For some people like myself, the OTC inhaler is more of a supplement to my doctor supervised treatment when I'm either in a financial bind or I can't get seen in time.
Being able to breathe is worth it; even if it's an OTC inhaler until I can visit my PCM at the VA, is a life saver in a pinch. On another note, thanks for working in the medical field we need more of you doctors really bad.
VA Patient,
Thanks for your post as well as your service to our country. Though we don't seem to have sense enough to provide health care for all our citizens, we at least have sense enough to provide coverage for our Veterans. Having trained and done some after hours work at a VA, I know that being a VA patient is not always easy. However, you do have access to health care and therefore should never be but in a situation where you need to rely on OTC inhalers.
If you have asthma, an albuterol inhaler should last you 6 -12 months. If you need it more frequently than your asthma is not under good control and you need stronger maintenance or every day medicines.
If you have emphysema/COPD (which many of our Veteran's have since our military decided to give our servicemen free cigarettes), then you unfortunately may need a regular rescue medication. In that case your rescue inhaler should last at least a month and your doctor should give you adequate amount of refills. If your rescue inhaler does not last you a month, then your COPD is not under good control and you need more everyday medicine. Most COPD patients in our country take two every day inhalers in addition to a rescue inhaler.
Please see your VA doctor and make sure you tell him or her how often you are using your albuterol and that you need to rely on OTC Primatene on occasion. With this information, they should be able to help.
So what happens when u can't afford to go to a doctor and when u have the condition that u need the med without it ur gonna die anyway so who is the government to do it and who do u think u r ? All u drs r ever interested in is MONEY not the people cause god knows if u don't have money or insurance u sure in the hell won't take care of a sick person. I wish all of u would go through what a real person goes through one day then maybe ull change ur mind . Get off ur high horse this med helped people with asthma that can't afford to see a dr all this is is the government s way of KILLING off poor people!!!!!!!
It seems to me as though this product helped more than harmed. I definitely suffer fromchronic bronchitis and last year I was prescribed an inhaler that really did help, however, ihave no insurance and went to the community clinic. It cost $125 just to be seen, plus $75 for the inhaler. I am still waiting to get into a local community healthcare clinic that has a sliding scale fee but until then i get to pay that price agaib tomorrow for the same Dr. That sawme last year to prescribethatsame $75 inhaler wheni could have gotten primatine cheaper and faster. I also do not believe you need a medical degree to understand symptoms and to draw your own conclusions regarding treating health issues. I have been treating mine and my family's ailments for years with herbal remedies after consulting books with bith conventional, herbal, dietary, and homeopathic remedies. I have successfully diagnosed ailments and gone to doctors who have corroborated my research and agreed on what i believed certain conditions to be. I have also been to doctorsforserious reproductiveissues that were blown off by certain doctors and nurse practitioners who just didnt care enough to do more research so ive been on both ends of the stick and a medical degree doesnt mean anything if you cant or wont properly or ethically treat someone. I may only be an LNA but i know quite a lot about pharmacology and also how to properly read labels. Instead of taking these products off the market why not lobby for moreEDUCATION to help train people to properly manage and trear symptoms without conventional medical interventions......ohwait I know why because then America would no longer be mass media sheep just following along to the slaughter. If you educate and give more resources people wouldn't be hospitalized and dying from OTC misuse.
My father who is 79 and has been diagnosed with Emphysema for 7 years, takes Primatine and Ventolin for his lungs. As a long term smoker of 50 plus years, it's not only non-shocking, but a pretty good bet that he would have this disease. I am shocked however to see him continue to smoke/ and use the inhalers to alleviate his wheezing which as you probably can/ could guess has progressed to him now needing 02 therapy. I am a non smoker and almost 50. I begged him from the time I can even remember being around to stop. I would cut his cigarettes so they couldn't lite, but in loads to explode them, and write on them ' coffin nails' death stix' or more. What is terrible and sad is that I love him, and begged him to stop, and he didn't. He even was diagnosed with Lung cancer 5 yrs ago but is in full remission. He's a guy who lived his life on his terms, but alas, here has come an inevitabilty of the use of drugs and o2. I know of a few people who passed due to this disease and think that it's ridiculous that primatine could be as much of an ozone killer as the belching mills from china or any other industrial nation. The do gooder's in this country have the right mindset of doing what's right, but NOT at the cost of things like this. I truly hate to see a great guy like my dad who was a good provider, in his situation and think that what we really should be doing is PUTTING tobacco companies out of business rather than Primatine. The truth of nicotine and enhancements to cigarettes are the killers of more than the ozone. I'd imagine that the pollutants from initial and second hand contact are far more dangerous than all the cfc that is in the canisters of primatine. Far More!
I have relied on Primatine for many years and have never had any adverse effects. I probably over use it as well. To take this very effective treatment away from me and others like me is criminal. I have tried countless times to find a treatment that works, only to stay with primatine because it works. I am counting the days until I run out and my life becomes unbearable. Thank you EPA and all you other do gooders.
@ Dr. Mintz...
Please know that my comments here are not in any way personally directed at you or any specific physician, because I do not believe that physiucians are evil or out to harm people or take advantage of them. What I do believe is that the medical industry as a whole is just that - an industry - anbd it has Big Government and Big Pharm backing it up because that is exactly how they make their money. I would venture to say, Doctor, that you pay more income taxes than many of the unfortuante souls on this board, so you are more valuable to Government than low-income asthmatics who can't afford a $50 office call. That is not your fault; it is the nature of the beast.
That said, I appreciate your assistance in offering me advice on clinics in my area, but this is just an example of what I am talking about about the naivete that "There are free clinics and things you can do." No, there are not. Don't you think people have already looked? If there was a solution, surely there would not be all these posts on your blog, complaining about the criminal act of sentencing millions of lower-income Americans to a potential death based on the fact that they cannot afford to step foot in a doctor's office or a clinic because they have the audacity to work beyond the point of qualifying for assistance but below the point of being able to afford a $50, $125, or more office call, on top of constant prescription costs. Surely you see that those prescriptions do not even work for everyone, even after people fork out the money to have someone write them out for them. I am not the only one on this blog who will suffer the loss or harm of a loved one while the ozone goes protected (allegedly). When medication is not affordable, and medical treatment is not available to the masses because of income, people have no choice but to self-medicate, and when that option is taken away, people have no choice but to suffer. It was kind of you to offer to send me to your friend in Bowling Green so my husband could get help, but that doesn't solve the problem for the millions of others who will possibly die or find themselves missing work, stuck in ERs, bankrupted, and having to choose between their kids' dinner and their ability to breathe. Pulling Primatene is a statement to the masses that the necessities of the common laypeople in this country are not as important as politics, income taxes, and environmental concerns, and that is a sad, sad statement indeed. It's nice to know the squirrels and trees will be able to breathe at the expense of human life because that $18 inhaler that we used to be able to buy when we needed it has now fallen victim to red tape and a scheme to force people to pay dearly for the right to breathe. I suppose it's a lesson we should have all learned at birth: It took a huge amount of money for us to be born in a hospital and have a doctor slap us to get us to take our first breath, and the medical industry is still trying to slap us with something before we can breath. And yes, it IS an industry. Frankly, it is a crime that the medicine was pulled without a replacement, becuase it directly endangers masses of people's lives, and anyone who supports it is a criminal party to standing by and watching people suffocate on the grounds of saving the environment, when we all know the only thing being saved is the hassle of having to deal with the uninsured and those who are not in higher tax brackets. Again I say, way to weed out the little guy, world. Maybe you should just start starving us too, or just shooting us on sight based on our 1040.
I'm sorry to repeat what everyone else has said, but I have also been extremely upset about this. I wrote my senator but only got a form email in response. It seems there is nothing more to be done - the pharmaceuticals and health care companies have won. Again. It wouldn't surprise if aspirin is eventually taken off the market too.
My father had severe asthma and after a trip overseas where I ended up in the hospital, I was put on a prescription inhaler. I suddenly found my condition was much, much worse; I had seen this same thing happen to my father (one reason I never used an inhaler). I forced myself off and used Primatene for years. When I got pregnant I was again forced to go on albuterol. I agreed for my child's sake but afterward went back to Primatene. We're talking years with no problems. Now it's back to the awful albuterol. One problem, I believe, is the way albuterol is metabolized by the body; some of it remains and that seems to aggravate the condition, not help it. Adrenaline is produced naturally by the body. What studies have been done? I've seen very little.
@ Lori
It doesn't matter the negative effects of how albuterol is metabolized by our bodies. What seems to truly matter is the effects of Primatene on the freaking ozone - and even more so, the effect of its availability on the bank accounts of insurance companies, doctors, and the government's income taxes. I hate to be so harsh, but any person who is honest enough to admit what is truly happening will clearly see that it is simply a matter of human life being placed on a sliding scale of value. Common people who need to buy their inhalers at Kroger or Walmart instead of forking out big bucks to see a doctor and then for prescriptions are less valuable to the government than higher-earning ones and the environmentalist PACs that place human health behind the importance of an alleged hole in an alleged ozone. Interestingly enough, cigarettes are OTC, and they SAY ON THE LABEL that they cause cancer, not to mention we all know that they pollute the almighty environment. Alcohol is OTC. For that matter, Big Macs are OTC. Why? Because all these things make money for the medical industry by making and keeping people sick, and the medical industry then, in turn, pays heavy income taxes. Money makes the world go round, and that $16 inhaler at Walmart wasn't earning enough of it for somebody. My husband has enough of a borrowed inhaler to last two more weeks. If there are to be regulations on things, it should be on the government sentencing people to an early death.
Check this out:
http://www.belaitsite.com/
FDALetter/houseofrepresentative3B.htm
I too am an asthmatic and am trying to breathe without the use of Primatene Mist. I now have a Ventolin inhaler, and I get very minimal, if any, relief.
Sitting here, wheezing, I've read every single post, and I have no words at how depressed I am knowing that this is the best my breathing will ever be for the duration of my life.
Good luck, Ms. Bela Feketekuty. I'm about to draft my own "request."
Dr. Mintz - I'm 43 years old, a professional engineer, and have had asthma since I was 14 years old. Its funny how you vigorously defend albuterol and so against Primatene Mist, but in one of your own posts you admit that there is NO data on how dangerous, or not, Primatene Mist is. And you somehow just know "it's as dangerous as albuterol". There is no data so you can't make that kind of claim. It's ridiculous. If Primatene Mist was so dangerous or associated with deaths it would have been pulled off the shelves years ago (The big name pharmaceutical companies would have made sure of that). It’s a cheap shot to get it banned because of the little bit of CFC it contains. FACT is I have used ALL of the different brands and treatments over the years (Alupent, Provental, Serevent, ProAir HFA,etc.. including you precious corticosteroid combos like Advair. Those treatments can be expensive, far less effective with much greater risks and side effects than the low cost OTC Primatene Mist which I have turned to when ALL those others failed. This whole issue is about control and money, period. I know my comments will not be posted but as you read this just know that there are educated professionals out here that understand what is really going on. We do write letters and have a voice. I will continue to get Primatene Mist through other sources, until those sources deplete, as I can afford too. I feel sorry for all the people who will suffer because of this and you as a doctor should put their health and well being above all else. You sir are part of the growing problem within the medical community of the big pharmaceuticals controlling the FDA and our doctors.
Dr. Mintz - I'm 43 years old, a professional engineer, and have had asthma since I was 14 years old. Its funny how you vigorously defend albuterol and so against Primatene Mist, but in one of your own posts you admit that there is NO data on how dangerous, or not, Primatene Mist is. And you somehow just know "it's as dangerous as albuterol". There is no data so you can't make that kind of claim. It's ridiculous. If Primatene Mist was so dangerous or associated with deaths it would have been pulled off the shelves years ago (The big name pharmaceutical companies would have made sure of that). It’s a cheap shot to get it banned because of the little bit of CFC it contains. FACT is I have used ALL of the different brands and treatments over the years (Alupent, Provental, Serevent, ProAir HFA,etc.. including you precious corticosteroid combos like Advair. Those treatments can be expensive, far less effective with much greater risks and side effects than the low cost OTC Primatene Mist which I have turned to when ALL those others failed. This whole issue is about control and money, period. I know my comments will not be posted but as you read this just know that there are educated professionals out here that understand what is really going on. We do write letters and have a voice. I will continue to get Primatene Mist through other sources, until those sources deplete, as I can afford too. I feel sorry for all the people who will suffer because of this and you as a doctor should put their health and well being above all else. You sir are part of the growing problem within the medical community of the big pharmaceuticals controlling the FDA and our doctors.
@anonymous 2/19,
Let me be very clear on my position. I object to rescue medications of any type being over the counter, because I do not think it is safe for asthmatics to manage their own disease without the supervision of a physician. There is very clear data that over use of beta-agonists correlates with worsening asthma, hospitalizations and death; and over use of beta-agonists are much more likely if not supervised by a physician.
I recognize that this position is not popular by many of the posters here because it requires a visit to the doctor, which is expensive if you don't have health insurance. Our health care system is terrible in that so many don't have access. However, this does not justify bad medicine. Furthermore, there are options for free care across the country.
"If Primatene Mist was so dangerous or associated with deaths it would have been pulled off the shelves years ago." This is not entirely true. The burden of proof for "dangerous" is far greater for over- the-counter than prescription products. Tylenol is a perfect example. Tylenol is a very dangerous medicine if not used appropriately, and it is very clear that Tylenol has killed many people. The problem is that in order for Tylenol to be pulled from the market (which I am not necessarily advocating) it would have to be proven extremely dangerous even with normal use. Very few OTC's get pulled. Contrast this with something like Avandia, where there has not been one actual study proving it causes harm (and one study that proves it doesn't) and now there are so many restrictions, the FDA has essentially banned this medication.
As far as albuterol vs. epinephrine, there is no study that compares both products head to head, so there is no clear evidence that one is more harmful than the other. It is clear that epinephrine has more side effects than albuterol, so in theory it is more dangerous. Again, if there is a clear reason for Primatene to be available for those that do not respond to albuterol, I have no problem with this being used, as long as it is under a doctor's supervision, i.e. a prescription.
Lastly, though I try to be as environmentally friendly as I can, I have no idea what damage the CFC's in asthma medication would do to the ozone layer, and therefore am not a proponent of removing these medications for this reason. That said, I am in favor of Primatene being off the shelves because I think asthma self-management is dangerous.
"This whole issue is about control and money, period."
You are certainly entitled to your opinion. In my opinion, the issue is about public safety. Asthmatics who are using Primatene without the guidance of a physician are at risk for severe consequences including death. I don't want to see any more deaths from asthma.
You (and other physicians) claim you don't want to see any more deaths from asthma, and that's commendable, but if that's the case, perhaps you should leave your profession, because I assure you that the removal of Primatene--many people's only chance of breathing due to ease of access and affordability--you are going to see countless more asthma-related deaths than you have ever seen before. Just because a doctor writes a prescription on a piece of paper, that doesn't mean it's any safer than the things people use at their own discretion. While there is some validity to the argument that doctors know more about the reactions people may have to medication, those living without any ability to buy any medication know far more about the reactions people have to having no help whatsoever. All prescriptions really ensure is that doctors, insurance companies, pharmaceutical companies, and the government by trickle-down get their cut. If this is not true, prove it. Stop backing the pulling of medications, herbals, and other remedies that help just as well (in some cases better) and just as safely (in some cases more safely) as the chemical crap you are scribbling down on those prescription pads that you probably got free from a pharmaceutical company trying to get you to peddle their products.
@autiej
"All prescriptions really ensure is that doctors, insurance companies, pharmaceutical companies, and the government by trickle-down get their cut." I won't disagree with this, but this is a system that I didn't design. I can tell you that if primary care physicians are getting their "cut", we got the raw end of the deal. I will not disagree with you that the health care system needs a lot of improvement. This is not the point of the post. I would support ALL medications being available to ALL people without any cost to the patient.
"Stop backing the pulling of medications, herbals, and other remedies." Other than Primatene, I have not backed the pulling of any medications. In addition, I am not even saying we should pull Primatene. My issue is that it should not be over the counter.
"herbals, and other remedies that help just as well (in some cases better) and just as safely (in some cases more safely) as the chemical crap you are scribbling down on those prescription pads."
There is absolutely no data the herbal medications are better than prescription medicine and are safer. Patients spend billions of dollars on vitamins and herbal supplements of little proven benefit. There are a few supplements and herbals(calcium, vitamin D, possibly glucosamine, possibly saw palmetto) that are actually safe and effective but most are "crap." In regards to actual over the counter medications (Primatene, Ibuprofen, Prilosec), most were prescription before they were over the counter, so to suggest that what I prescribe is "chemical crap" and the Primatene you can get over the counter is any different is simply not true.
Finally, and most seriously, in regards to deaths from asthma; perhaps I did not make my reasoning clear.
If you are using Primatene once a week or less, then it is probably OK, and risk for death is probably pretty low. However, most patients who take Primatene take it more than this, and in fact, many use it several times a day. The problem with this approach is that it simply treats the symptoms of asthma and not the underlying cause of asthma, which is inflammation. According to the NIH and WHO guideline, patients taking rescue medications more than twice a weeks should be on an inhaled corticosteroid. Allowing Primatene to be sold over the counter substantially increases the risk of patients taking too much rescue medication without an anti-inflammatory. This in turn increases the risk for hospitalization and death.
I never said Primatene was different. What I said was that the difference is that doctors, and Big Pharm and Insurance profit from anything that is not over the counter. THAT is the only difference. Evidence? You've spent this blog arguing how dangerous Primatene is, yet now you say you'd be willing to prescribe it as long as it is not over the counter. That sickens me further. Again, it is a matter of who is profiting off the illnesses of others. And I will not argue with you about herbals, because any medical doctor will argue against their validity. I am not to blind to see why, since it - like Primatene - keeps many people from paying for prescriptions and doctor visits. In fact, most of those chemical medicines you prescribed are derived from herbals. I have seen with my own eyes and in my own body that they do, in fact, work - often better and safer than synthetics. You can argue all you want with statistics and studies, but I know they have worked for me and for people I care about, and that is the only statistic I need. I know that at 3 a.m., when we have no money to go to a doctor or to fork out for an E.R. bill, Primatene has kept my husband breathing. In any case, this is a pointless argument. The medical industry refuses to admit that it is, indeed, an industry - in it to make money by profiting off a guaranteed income source because all of our health is doomed to fail over time. It is ironic - or maybe not - that medications are pulled once it is realized that they are not bringing in a profit for that giant industry. I don't believe doctors are evil or greedy on a case-by-case basis, but if people can find remedies outside the insurance-doctors-big pharm circle, somebody loses big bucks, and that is simply not tolerated. We should all be entitled to benefit from human advancements in medical science, but unfortunately, that privilege is limited to those who can pay ridiculous prices for it. No family should ever have to decide between one of them breathing and the rest of them eating. And when over the counter aides that work are pulled so they can be regulated and profited from, many families have no other option than to make such a choice. READ the posts here. SEE that Primatene works for many people. ADMIT that it the medicines you prescribe (and profit from) offer just as many threats and side effects and sometimes less help. And then, for the sake of your oath to help people, DO something about it.
@autiej
You seem to imply that physicians, drug companies, and environmentalist all sat down together and said, "OK, how can we stick it to the poor and sick and make money while doing it.?"
Though all three parties have not been perfect, I find this scenario that you imply in your post far fetched.
Clearly, the environmentalist who went after the CFC's and the agencies that approved their withdrawal probably did not consider the unintended consequences for asthmatics. The biggest one of which is increased costs to patients for prescription medications.
"No family should ever have to decide between one of them breathing and the rest of them eating." You are 100% right. We need real solutions to our health care delivery system now.
However, this is not the point of my post. The point of my post is very simply that asthma is a serious disease and should not be self-managed by patients.
i had insurance until i married and they decided that since my husband made a few extra dollars i wasnt disabled anymore. i have no insurance and chronic astmah. i have used primeatene inhalers and got relief. the 9 dollar walmart inhalers DO NOT EXIST i called. theya re trying to kill off the sick ppl first. its plain as day or they would provide something affordable to ppl who cant AFFORD INSURANCE!!
Dr. Mintz- I commend you for offering this blog and reading and truly answering comments left here. I found your blog after feeling extremely lousy all day. I had used an abuterol inhaler many times over the course of the day with very mild results. I was feeling bad, wondering how I was going to make it through the night feeling like this, wheezing and coughing up mucus. Finally, out of desperation, I pulled out an ancient, expired Primatene inhaler I abandoned after being told it was terrible for those with high blood pressure and being prescribed the abuterol. One puff and seconds later complete relief that has lasted for hours now. Not a single cough after the puff with several hundred coughs in the preceding part of the day. I feel like a complete idiot for listening to the doctor and ignoring my own knowledge and instincts. I went from feeling horrible to wonderful in seconds. Thank god I did not dispose of this wonder drug. I am currently feeling delightful for the past several hours thanks completely to one single puff of Primatene. I note your compassion and care...you sound like a wonderful doctor. Unfortunately, in my personal experience, you are as rare as the golden ticket in Willy Wonka. I have had nothing but terrible experiences with doctors, optometrists and dentists in my 40+ years. Con artists as a group; I trust a 3-card monty dealer on the streets of New York more that most doctors I have come into contact with. From mistakenly drilling the wrong teeth, oh nevermind...just thanks for being one of the good ones...
I used primatene for years. I have prescriptions for advair and albuterol. Generally my asthma is under control. However if i have an asthma attack the albuterol is no where near as effective as primatene. The feeling of suffocating is a very unpleasant experience. Primatene needs to be brought back until our simply idiotic government can come up with a suitable replacement.
Clearly from some of the people commenting on this blog, some patients are less responsive to albuterol that epinephrine (Primatene). I am not aware of alot of comparative studies validating this, but variable responses is common with any medication. I have no problem bringing Primatene back to the market. I just don't want it being used without a doctor's supervision.
@ "I just don't want it being used without a doctor's supervision" = "We just don't want it being used without someone making money off the office call and prescription." The truth is, if the "danger" was really the reason for it being pulled, we couldn't buy cigarettes, alcohol, aspirin, caffeine pills, or freaking fast food over the counter. ALL of those are known to be dangerous and even fatal at some level when abused, yet they are still for sale because they are not able to be forced into prescription only. It is a money thing, plain and simple. On the Walmart shelf, Primatene doesn't make money for Big Med or Big Pharm. We may not all be wealthy, but we are not idiots...and we're not too stupid to see what's really going on.
@autiej
I have tried to be respectful regarding all of your comments and concerns. I have provided you with information about getting free care for you and your family, and even personally reached out to a physician not too far from you that would see you for free.
However, you continue to suggest that there is some conspiracy between Big Pharma, the government and doctors where they collectively decided make of some BS environmental reason so that we could deny therapy for patients in order for Big Pharma, doctors, and even the government to make a few extra bucks. This is simply ridiculous, and I can not continue to respond to this line of thinking.
I will not argue the merits of the danger of CFC's from MDI's. I am not clear that the tiny benefit this might have provided to the environment was worth the potential harm and additional costs for patients who need these medications.
However, I can tell you that primary care physicians are not making big bucks off of patients who now need to be seen to get a prescription of albuterol. If you have been paying attention to the national debate, there is a huge primary care shortage. We do not lack for patients. There are plenty of patients to fill appointment slots. No need to require visits for previous Primate users in order to pad our wallets.
The issue here is not about money, but about access to affordable health care and the appropriate practice of medicine. It borders on criminal that our society can not ensure health care services for all of our citizens, especially when most other countries have figured out a way to do this. Nonetheless, just because patients do not have access and coverage for healthcare costs, this is not an excuse to practice bad medicine. Using Primatene without the close supervision of a physician is indeed bad medicine.
Thank you for your insightful opinion Doctor. I do agree that primatene is dangerous, i know its not great on the heart. My problem is, albuterol works only in neb treatment for me anymore. The old CFC albuterol inhalers were great, for the most part. But even those i built a high tolerance for, using 3-4 puffs to clear up tightness, but the HFA albuterol inhalers have actually made my attacks worse at times. They never seem to reach the lungs, and yeah they have a cheap one for 14 bucks, but it literally only lasts me a week, with use of it once a day. That is unacceptable! I also understand it is best to get prescriptions under the supervision of a doctor, well thats fine if you have health coverage. The drugs my docs want me on, are insanely expensive. Now i do see this as an angle for the drug companies to capitalize. They will have a brand new patent, like they did with albuterol HFA and mark up the OTC price astronomically because walgreens and walmart wont be allowed to make a generic version. Please doc, with all your health logic aside, is it not better for someone to have a fast acting relief inhaler, that can SAVE them, or to not have anything and be forced to live in fear hoping a damn cup of coffee will clear them up, if they are so lucky to even be near home or coffee. I can tell you, i will not be able to go camping this summer, or anything that is outside of a hospital drive. This makes me wish i could grab a million 1980's hairspray cans and find these damn lobbyists and spray 100 tons of CFC in their face's! Anyway, the reason they took it off the shelf is absurd and it WILL result in people dying. So much for the whole "If it only saves one life" mentality. My rant is done.
Thank you for your insightful opinion Doctor. I do agree that primatene is dangerous, i know its not great on the heart. My problem is, albuterol works only in neb treatment for me anymore. The old CFC albuterol inhalers were great, for the most part. But even those i built a high tolerance for, using 3-4 puffs to clear up tightness, but the HFA albuterol inhalers have actually made my attacks worse at times. They never seem to reach the lungs, and yeah they have a cheap one for 14 bucks, but it literally only lasts me a week, with use of it once a day. That is unacceptable! I also understand it is best to get prescriptions under the supervision of a doctor, well thats fine if you have health coverage. The drugs my docs want me on, are insanely expensive. Now i do see this as an angle for the drug companies to capitalize. They will have a brand new patent, like they did with albuterol HFA and mark up the OTC price astronomically because walgreens and walmart wont be allowed to make a generic version. Please doc, with all your health logic aside, is it not better for someone to have a fast acting relief inhaler, that can SAVE them, or to not have anything and be forced to live in fear hoping a damn cup of coffee will clear them up, if they are so lucky to even be near home or coffee. I can tell you, i will not be able to go camping this summer, or anything that is outside of a hospital drive. This makes me wish i could grab a million 1980's hairspray cans and find these damn lobbyists and spray 100 tons of CFC in their face's! Anyway, the reason they took it off the shelf is absurd and it WILL result in people dying. So much for the whole "If it only saves one life" mentality. My rant is done.
@Mistoffbeyondrelief
Thank you for your comments. I don't know your entire medical history, but in general, there is reasearch that tolerance of albuterol is diminished when patients use inhaled steroids. This is probably also true of Primatene. Don't know if you have been taking an inhaled steroid in addition to your rescue albuterol. However, this is why I believe asthma must be managed under the supervision of a physician. I realize that drugs are very expensive and not everyone has prescription coverage. However, the drug companies do have a variety of programs to help patients pay for their medications. For patients who have insurance (not including Medicare) most medications can be aquired for less than $25 a month (which I know is still a lot for many people, but still within reason). For patients without insurance, most people who are poor but aren't poor enough for Medicaid can get there medications for free by signing up for programs sponsored by drug companies. The process is not that horrible, but it does take time on the doctor's part, which is why many doctors may not even suggest these options. However, these options are both available and underutilized.
oh i so agree with this. Really they are worried about cfc coming out a 1.75OZ BOTTLE but look at whats coming out train engines and semi trucks. Please someone is paying off someone......
I can't use a corticosteroid. Even light doses result in joint pain.
What then? One small albuterol per year?
Meanwhile. Intal, a wonderful harmless preventative, has been pulled from shelves.
Seems there is one game in town: corticosteroids... let's see whose wallets are lined and who pulls the strings behind all this altruistic blather.
@dougcl
Inhaled corticosteroids remain one of the most significant advances in asthma therapy. No other agent comes close to their efficacy. In addition, at low to medium doses are safe. Prior to inhaled steroids, severe asthmatics needed oral steroids which causes horrific side effects.
In general, inhaled steroids should not cause pain in joints. In fact, joint inflammation/pain/swelling is generally treated with anti-inflammatory medications, steroids being the most potent. The amount of inhaled steroids that get absorbed in the blood stream is not likely enough to significantly help or harm ones joints. However, every patient reacts differently to different medications. I would strongly recommend working with a physician that is an expert in asthma to help you manage you situation.
In fact, your situation highlights the main point of my original post, that asthma is complicated. Asthma treatment requires working with a clinician who has expertise in asthma. It is not something like a headache or heartburn where a reasonable adult can safely and usually very effectively treat his or her own ailment. The problem I have with Primatene is not any theoretical risk it poses to the environment. The problem I have is that it allows patients to manage a very serious medical condition without physician supervision. While I understand that due to our broken health care system, requiring a doctor's prescription/visit makes this financial and logistically difficult if not impossible, I don't believe there is enough justification to allow patients to self-treat asthma.
As I read all of this it sickens me. I was diagnosed with asthma when I was 12 years old. I have been struggling with it for 26 years now. I have tried all the other inhalors and none of them worked. At least not as well as primatene. As far as it harming the ozone, BS!! There are a lot of things out there that are harming our inviroment far more than primatene. You keep saying, " have your asthma evaluated by a doctor" even though people keep saying they can't afford one. If doctors these days didn't think a couple of minutes of their time was worth our life savings things might be different. Doctors use to actually care about their patients. Not true of the doctors today. Seems all they really care about is the jingle in their pockets. I am not attacking you personally and it is not true just for doctors. Seems that's all anyone cares about these days and it's a DAMN SHAME. As far as the side effects. You can say that's what it is about all you want. Doesn't make it true. Just because you get a prescription from a doctor it doesn't make the side effects any less severe. If you watch tv on any given day it always seems that 2.5 minutes of a 3 minute commercial is listing side effects including death. There seems to be more lawyers trying to get you to sue manufacturers of medicines than there where episodes of the Andy Griffith show. The bottom line is that Doctors, Pharmasutical companies and the government alike just flat out don't like competition. They can't stand to see anyone getting a piece of their pie and that's exactly what low cost over the counter drugs are doing. Yes some people have access to free clinics but not all. Yes you might be able to get free samples from a doctor but you have to be able to afford to go see one first. You saying that we can always just go to the ER because they have to see you whether or not you have insurance is laughable. The last time I went to the ER they charged $100 on site before I could leave. That wasn't counting the other bills. Then when you can't pay the bill they take you to court, it goes on your credit and so forth. Then it ends up costing even more money you don't have. Primatene costed little money and we got the relief we needed without it costing us an arm and a leg. You keep saying we shouldn't self treat but when we can't afford to see a doctor every few weeks what other option do we have? Some of us know it is asthma because we were already diagnosed with it and it should be our right to choose whether we want to buy an affordable medicine or fork over a couple weeks pay to go get one from the doctor. As some of the others have said before, its a money game. I can guarantee that the use of primatene doesn't have near the impact on the ozone as factories, power plants, vehicles and so on. It's just like when we were back in school. The bigger the bully the more problems they cause. One can only hope that one day the big guys will start looking out for the little guys instead of picking on them.
The danger of Primatene is not it's side effects, though it does (for most patients) have more side effects than prescription albuterol. The danger of Primatene is that it is a rescue or emergency medicine. It should be used more than twice a week. Anything more than that without means that asthma is out of control and is dangerous. This is why asthma must be managed by a physician, and usually involves the use of controller medications, which are only available by prescription.
So many people have responded to this post by stating that they can't afford to see a doctor or take prescription medication. This is tragic, and clearly shows that are entire health care system is broken. Every American should have access to affordable healthcare.
Thus, the question is should we condone poor medically care (letting asthmatics take Primatene whenever they want and without the supervision of a physician) because people don't have health care coverage. I believe we shouldn't. There are ways to get free or low cost medical care in most areas and most drug companies will provide free medications for those in need. I understand that this may not be convenient, but the alternative which will lead to patient deaths is not acceptable to me.
"There are ways to get free or low cost medical care in most areas and most drug companies will provide free medications for those in need. I understand that this may not be convenient, but the alternative which will lead to patient deaths is not acceptable to me."
Until there are "ways to get free or low cost medical care" in ALL areas, it has nothing to do with convenience. "The alternative, which will lead to patient deaths" may not be "acceptable" to you, doctor, but what is not acceptable to the millions of people in this country who cannot have their health tended to because they cannot afford it is that their deaths will be the result of greed and misplaced priorities. This is not directed at you personally, but your argument that people should not be allowed to care for themselves because it is dangerous is weak from the standpoint that SOME care by themselves is better than NO care because they can't afford it. Have you read the posts here at all? If people cannot breathe, they cannot live, and many cannot breathe because they cannot pay. They could breathe with Primatene, whether it was the healthiest choice or not, because at least it was a choice. The alternative to THAT is what is not acceptable to me.
@autiej
Here's where we completely agree:
"what is not acceptable to the millions of people in this country who cannot have their health tended to because they cannot afford it"
Here's where we disagree. Care is available. In the US, the poorest have Medicaid. The gap exists between those not poor enough to have Medicaid, but do not have health insurance from an employer or other means. For those people (and 50 million is staggering), there are options. Between free clinics, pro bono care provided by some doctors, and programs from the drug companies; patients can get care. It may be extremely difficult, i.e. travelling long distances at inconvenient times, but it is not impossible.
If it were truly impossible to get medical care without health insurance, I might agree with you.
"free clinics, pro bono care provided by some doctors, and programs from the drug companies"'
This is simply not true. You may believe it to be true or have been told to believe it to be true, but it is really just propaganda, a nice little distraction when someone wants to control people as we are being controlled and exploited when it comes to our own health. Free clinics are not free for most people. Pro bono care seldom happens in real life (though it sure looks good in the movies), and "programs from the drug companies"? If there are, they sure do a good job of hiding themselves from people who could use them. It is naive to think these programs either exist or are easily and widely accessible, because they simply are not, even if it is the robotic response programmed into doctors to say when someone complains. The vast majority of that 50 million cannot benefit from any of these programs, which is one reason why Primatene should not have been pulled. If these programs were so widespread and available, this blog would not go on and on and on with people complaining, would it? It has nothing to do with driving distances or inconvenient times, as I'm pretty sure someone would be willing to go at any time to save their life, especially to be able to breathe. It has to do with M-O-N-E-Y. Did you not see the post from the man who was forced to pay $100 before he could even leave the ER? Have you not read the posts here that have said that even with so-called free clinics that are seldom free, prescription medication, combined with office call costs, still force people to choose between eating or feeding their children and breathing? Primatene may not have been your choice for people's care, but ultimately, it is their health and should be their choice - not yours, not the government's, and certainly not the pharm companies who want to make a profit off of it. You admit that it is "extremely difficult," and when someone is struggling for their next breath, they don't have time for difficult. But it is like talking to a wall... a very big and powerful and greedy wall who refuses to hear what the people are screaming and justifies its existence by reciting the self-justifying lies that "oh, but we've provided another way," even when that way does not really exist. As I've said before, we may not have medical degrees because we work in different careers, and we may not have very much money or live in big houses or drive fancy cars, but we are not stupid, and we see what is going on. Primatene was pulled because someone was not making enough money, period. It wasn't pulled for the environment, or cars would be illegal by now. It wasn't pulled because Big Med really cares about its effects on our health, or cigs and alcohol would have been pulled a long time ago. It was pulled because it allowed people to choose their own "affordable alternative" - and the medical industry doesn't like those two words for sure.
@autiej,
We are going to simply have to agree to disagree. Free clinics and medication programs do exist, though they may be difficult to find or get to. I have personally given you several options for you and your family, so I know these exist at least for you. I am not trying in any way to diminish the fact that this is still unacceptable. People should have easy access to affordable health care.
In regards to your other theories about why Primatene was taken off the market being about "money," I will not argue simply because I don't have proof that this is not the case. However, you seem to imply that doctors, drug companies, environmentalists, and the government (or some combination) met and conspired to "stick it" to the poor in order to make profits. There is really no proof for this either. (Though I would be open to the idea if you had any evidence other than "now people need to go to the doctor to get a more expensive prescription").
That is proof enough, friend. I do not believe doctors, on the whole, are evil or are out to get anyone, as no one would spend thousands of dollars putting themselves through medical school and spend their days treating illnesses and listening to sick people unless they had some shred of compassion. What I do believe, however, is that Big Med, Big Pharm, and the government do, in fact, try to stick it to the poor people - the "surplus population," as good ol' Ebenezer would have put it - because they are easy targets. It is a bully-picks-on-nerds-because-he-knows-there-will-be-no-viable-resistance conundrum. It is easy to win a war against opponents who cannot fight back, and the impoverished or hardworking people who barely eke by have been the targets of taxes, fees, and governmental control for far more generations than this one. The fact that "now people need to go to the doctor to get a more expensive prescription" IS the proof of this. You only don't see it because you are not suffocating beneath the weight of that reality. As far as you offering assistance to me personally for my family, that is highly commendable, but that does nothing for the millions of others--including the ones on this board--and it is not a burden that is yours anyway. I think all people are looking for is someone to acknowledge that there is an evil going on, and that evil is that money HAS taken precedence over human compassion, and that we are no longer allowed to make decisions on medications that we want to use because our very bodies are being exploited for a profit. Deny it all you want, but the fact that Primatene is not on the shelves and cigarettes, fast food, and car emissions still are is all the proof I need. Marlboro will make their money, McDonald's will make theirs, Ford and Chevrolet will make theirs, and now the producers of albuterol and the doctors who have to give permission to buy it will make theirs because we have no alternative. Some need to keep people sick, and all need to make sure that the sick keep paying, whether than can afford to or not. So, yes, we will have to agree to disagree. But sometimes the only proof you need is a good look at what's going on around you.
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Here ya go, auntiej.
www.rxassist.org
I found this blog after being prescribed an Albuterol inhaler by my MD for a sinus infection with some chest congestion/wheezing and decided to do some searching on Dr. Internet for side effects/dangers/general information on inhalers since I've never used an inhaler before (scary things, inhalers - not sure now if I want to use it after all).
Anyway, I do agree that "Big Pharma" is out to make a buck. Every single company on the planet is out to make a buck. Why else do companies exist, right? If people hadn't figured out that whole mass production thing we'd still be working off the land and trading chicken eggs for a scrap of burlap to make that new Sunday-Go-To-Meeting dress.
We'd also still be dying from tetanus, tuberculosis and diphtheria at alarming rates. So medical research and Big Pharma have done a bit of good here and there.
And before I go further, no I do not work for a pharma company. I also am one of the 50 million who does not have health insurance. I paid my $75 office visit today out of pocket and I will have to pay for the meds out of pocket. The Albuterol is going to cost me $45 for the generic, the prednisone is another $25 and the antibiotic $4.
I missed work today, so that's another $100 or so.
So who am I angry with?
Dr. Mintz? Nah, he didn't shove that pollen up my nose.
My MD? Well, $75 for less than 2 minutes of your time is a bit much, but there's that whole building you have to pay for - not to mention the light bill and water bill. And salaries for the front desk clerk, filing clerk, referrals clerk, appointments/phone clerk. And the person who has to hunt down my chart every single time I call for a prescription refill. And the nurse. And accountant. And let's not forget the malpractice premiums.
Big Pharma? Nope. They're going to supply me with the medication I need to get better and not die of sepsis from an out of control sinus infection.
The Government? Yeah, maybe a little. But then again, I honestly don't think we're guaranteed health coverage by the constitution. "Pursuit of happiness and a cheap HMO" doesn't ring any bells.
The Insurance industry? NOW we're talking. The entire reason (I believe) health care has gotten out of control in this country is because of the insurance industry. Quite frankly I think the best thing for this country is to completely do away with private insurance. It's too expensive for the average consumer and doesn't pay the MDs as much as most people think.
My MD's office offers an incentive for self pay patients - 25% discount for an office visit that is paid in full at the time of the visit. Why? Because that's all the insurance company will pay and it cuts down on man hours required to file with the insurance company. Saves the office money in the long run.
In fact, I seem to recall a movement by some MD's who are starting to refuse insurance from their patients and go to a "fee for service" type of practice....which is resulting in lower office fees and better care for their patients.
At any rate, auntiej and Dr. Mintz I have enjoyed reading your discussion and think both of you bring up salient points, but I just couldn't help but throw "Big Insurance" into the bonfire.
And for the record, I would not dare use an OTC product that contains epinephrine without first getting approval from someone in the medical profession. And Dr. Internet doesn't count.....
There is no use arguing with that doc, he is like all docs of today, just put your life in my hands and if my medicine kills you (which thousands have died with side effects of prescription asthma medications), we'll say OH thats too bad but sure glad you didn't take the primatene (which I haven't read or heard of anyone dying from using so far). We want to control you just like the government, and all your money that the gov. doesn't get - we want. They are brain washed from the pharmaceutical companies who are making billions from these drugs and will do anything to keep them on the market and keep docs prescribing them. Even all the info you are given says to ask a pharmacist about it - AS THE DOCTORS don't really know about them. And they are still giving other drugs another 2 years before banning the propellent in primatene. I'm sure that propellent is really a big risk to us with all the other huge factory and car fumes around the world -yea sure. You can fool all the people some of the time and some of the people all the time but you can't fool all the people all the time and WE THE PEOPLE can see thru you docs and the pharmacutical companies and sky rocketing prices for meds and the control you want over everything over the counter. I seen your article on aspirin, etc., saying (No you didn't want to control it YET), that says EVERYTHING.
I also think that either the pharmaceutical companies and/or the doctors bought out the company that makes primatene which should have came up with another propellent right away as there are other propellents being used in other meds on the market, so something is fishy going on there too.
Watching this and big companies moving their industries out of the U.S., giving other countries bargain prices and us the shaft and you wonder why we don't BUY american anymore. Or have any respect for our doctors, etc.
Yes, snotnosedsurfer! Insurance companies are inherently evil! Hey, pay us a bunch of money every year just in case something happens. Oh but wait, when it does we will not cover that because it's a "pre-existing condition". Lab work? Oh no, we don't cover that either. I was actually told by a physician friend once that if he was a single man he wouldn't have insurance but rather would open a savings account just for paying medical bills should they arise. At the end of the year if he had not had to use it he would take a portion of the money and go on vacation.
Second behind the insurance racket is the drug companies though. Guilty, guilty, guilty!
I blame the doctors themselves the least of all for our healthcare issues in this country but they are not completely off the hook. As with anything, I think it depends on the individual. Some doctors really did go into their line of work because they desired to heal others. And some are in it for the money.
All this being said, I am one of the many asthma sufferers that have found better results from primatene mist than albuterol inhalers and have not had any success from the "longterm asthma control" medicines such as advair. In fact, my asthma improved after using primatene. I used to have a nebulizer that I needed several times a year. However, after using primatene for a while my nebulizer has collected dust in my bathroom closet for about 5 years now.
Sadly with the FDA ban I too am back to using albuterol in the form of a ventolin inhaler. Nowhere near as effective as primatene. Unfortunately I was a little late hearing about the imposed ban and was unable to stock up.
Dr. Mintz states that all primatene studies are outdated so I wonder why no one bothered to do a new one to support the argument that it's a dangerous OTC drug. Seems a bit irresponsible and opportunistic if you ask me.
People are complaining about the cost to the patient associated with this move and I can tell you it is pretty high. I do not have insurance or a regular doctor so off to the CVS minute clinic I went. $80 for the visit and $50 for the ventolin with only one refill prescribed. To get more I will have to go back and pay another $80 for the visit to get 2 more inhalers. What sense does that make? I have had asthma my whole life. Of course I'm gonna keep needing inhalers. I'm not magically going to stop needing them. Why can't I get more refills?
Healthcare reform is this country's biggest need right now in my opinion. Of all the issues on the table in Washington this one is the most important I believe.
Affordable healthcare for EVERYONE should be our goal. And that should be from the top to the bottom.
I miss my primatene. I hope that there will one day be a reasonable substitute.
Albuterol does not work at all!
I was diagnosed with chronic bronchitis when I was 16, and often have asthmatic outbreaks. I have been prescribed every inhaler in the book and none have had any results. Albuterol has been the most prescribed to me. The last time I went to the docs I had a bit of a wheeze going on and the doctor set up a nebulizer with albuteral. I told him of the lack of outcome I get from it. He gave me a breath test, then the nebulizer. Another breath test. Another nebulizer. I left the doctors with a worse wheeze and a prescription for albuterol. None the less, my primatene mist supply just ran out, and I have no idea what I am going to do. Any suggestions?
@theonlyjohnson
My suggestion is to find another doctor if the medication you usually got was albuterol. If you have chronic bronchitis since your teenage years, you likely have severe and complex respiratory disease. This should probably be managed by a pulmonologist. If you live anywhere close to a medical school, I would recommend seeing a pulmonologist that is full time faculty at that medical school.
Dr Mintz,
Thank you for your compassion. You are clearly one of the good guys.
If these safer medications were sold over the counter, than I'm all for other options. To be honest, I am not a "doctor" person. Of course, for some things, it is necessary. I mean, we really can't do our own surgery.
There are times when we should be allowed to be our own dr.s. We know our bodies and conditions and most of the time, we know what we need.
My point is, consumers should have access to many medications that are "prescription only". More over the counter options should be available.
I definitely understand and appreciate your perspective. However, I must disagree with your statement "There are times when we should be allowed to be our own dr.s. We know our bodies and conditions and most of the time, we know what we need."
Asthma kills over 4000 Americans each year. In the US, there are over 200,000 hospitalizations and 2 million ER visits due to asthma. Asthma deaths, hospitalizations, ER visits and exacerbations are all correlated to use of rescue medication. The more rescue medication an asthmatic takes the more likely bad things are going to happen.
According to the guidelines, asthmatics taking rescue medications (albuterol, Primatene) more than twice a week need to be on a maintaince/daily medication to prevent these bad events from happening. The best thing for this is inhaled corticosteroids. The problem is that patients will happily take Primatene or albuterol once a day or more not thinking there is anything wrong because they feel their symptoms are controlled. Though physicians need to do a better job tracking albuterol use in their patients, unrestricted use of Primatene is a huge concern for me because there is no way to track patients that are potentially in trouble.
Of course, there are many stable asthmatics that get by on rare use of Primatene and are certainly inconvenienced by needing a prescription. However, I think in the bigger picture this inconvenience is worth the prevention of even one asthma death. Now, as many responders to this post have mentioned, prescription asthma medications are expensive. Their response would be that there is no need to prevent me from taking Primatene once a day because I can't afford the inhaled corticosteroid you say I should be on. This is completely understandable and prices for prescription medicines are too high for many patients. However, every drug company has a program that people who can't afford medications can get them.
"Asthma kills over 4000 Americans each year. In the US, there are over 200,000 hospitalizations and 2 million ER visits due to asthma. Asthma deaths, hospitalizations, ER visits and exacerbations are all correlated to use of rescue medication." Right, Doc. But keep an eye on those statistics of yours, because I guarantee that over the next few years, since there is no nothing available and affordable over the counter, those numbers are going to go up. In the past, my husband had to go to the ER for his asthma once. Since they pulled Primatene, and we simply cannot afford office calls and prescription meds, we've had to make countless trips there and will continue to have to do so. A $50 albuterol inhaler doesn't last him any longer than a $20 Primatene one did (less time, actually), not to mention the $100 office call, even at the supposed community clinic for economically suffering folks.
@autiej
Our central disagreement is whether or not certain medications which may lead to overall bad outcomes should be made available over the counter, even with some risk, because access to affordable health care and medications is bad for many Americans. My opinion is that we should not allow this. We should try to fix the poor system that encourages patients to spend hard earned dollars on suboptimal medical care. Two wrongs do not make a right.
If SCOTUS does not boot the ACA, you and your family should be able to qualify for affordable health insurance in one of the many exchanges that will be offered in 2014.
Look at all the people suffering from asthma that disagree with you Dr.Mintz. It is you who is misinformed. Stop spewing the propaganda of the drug companies who are against OTC's. Your objective is so transparent; quite frankly, you make me sick.
I feel horrible for all the people suffering with asthma. This is why I went into medicine. OTC bronchodilators are not the answer. A good doctor patient relationship with appropriate medication is the answer. There is no question that our health care system has failed many Americans. We need to work to fix this. However, two wrongs do not make a right.
Yes, "we need to fix this," and it is good that people recognize and "feel horrible," but UNTIL it is fixed, Primatene was the only choice many asthma sufferers had. My husband now owes the so-called "free clinic" $200 just for going in there to get asthma prescriptions, which cost $50 and put our family in a bind every time he has to have a prescription refilled. THAT is not okay for families who struggle, like many of the people on this board. Two wrongs may not make a right, but one of those so-called "wrongs" was keeping people alive while the government flails about, flip-flopping over the other "wrong" that people cannot afford. OTC bronchilators ARE a good answer when the only other answer is "Sorry. No money for the ER, prescriptions, doctor visits equals no breathing." For many people here and out in the world, Primatene was the only answer, even if it is an answer you and the medical community doesn't see as ideal.
@autiej
$50 is certainly a lot to pay for medications for some people, but I don't believe it is so exorbitant to justify over the counter meds.
If your income is so low, you should be able to qualify for Medicaid. If you income is not low enough to qualify for Medicaid, and you don't have other insurance, you should be able to get almost any medication free through the drug companies. If you fall into one of those two categories, then you shouldn't really have to pay anything for prescription albuterol.
A lot of shoulds there, doctor, but that's what the people here are talking about. Those "shoulds" sound good on paper and when recited to hopeless people who need help, but if you read the posts here, you would know that those "shoulds" are just propaganda, like the poster up there said. And one man's definition of exorbitant is not another's. My family eats on less than $50 most weeks, so yes, it is exorbitant enough to justify us wanting the $16 back on the shelves. We could afford Primatene AND groceries. Imagine that. And we're definitely not alone, as the chain of comments on this blog attests to.
@autiej
"should's" are not propaganda. I would be happy to assist you and your family in getting medications you need.
If you are interested, email me directly at drmintz@gmail.com
Stumbled onto this blog post. Funny commenters.
Dr. Mintz, thanks for standing by your statement. Im a 3rd med student, and my preceptor was just telling me how dangerous he feels primatene mist and afrin is.
For the rest of you anonymous posters; just STFU. "Well, I've used cocaine lots of times and I feel great!" Thats essentially what you're saying. Just cause you've used it fine, you think its just dandy.
You think docs want to see patients like yourself for a few $? No, Im pretty sure they'd rather you dumb ungrateful shits just stay home and rot.
Don't even try to argue with me, cause you can't even spell right. You'll just embarrass yourself some more.
Whoa. @AuntieJ.
Stop blaming everybody else for your own life. I get it: You're broke, you're poor, you can't afford to see a doctor, etc. So you blame the doctor?
Do you blame the supermarket cuz you can't afford food? Or the gast station?
Nobody owes you jack shit. Every single word out of you is pure speculative garbage. Im sorry, did you do a survey of 1000+ people to get your medical data? Tell us about all the books you've read, the patients you've seen. You think a cancer patient is an expert on cancer? You think just cause you have asthma, then the world owes you something?
Dr. Mintz is a polite guy, so let me say it: @auntieJ, you need to wake the f up.
@ anonymous
First of all, it's autiej, which is short for my name. There's no N in it, just in case you're still worried about those who can't spell.
Second of all, if you took the time to read the posts here, you would see that no one thinks anyone owes them anything. Most of the people using Primatene were doing so because they had no affordable alternative, and that is what the complaints are about--a go-to remedy being pulled when it was the only remedy some had access to.
And third of all, I know Dr. Mintz is a nice guy. He has personally extended help to me for my husband's condition (by the way, you'd know, too, if you took time to read the posts that my husband has asthma, not me). The fact that he allows people to state their disagreements here and offers rational answers and rebuttals speaks to his demeanor and his character.
The comments here do get heated, because it's a heated issue. No, cancer patients do not know what's safe for them to take as much as doctors do, but if there were something they could take over the counter without having to fork out thousands of dollars (which many of them don't have, and that's more of a fact than a complaint), it would be an alternative for those living on the cusp. And for the record, how many cigarettes are sold every day? Those are pretty toxic to the environment and the people inhaling them by choice or force, yet they're still on the shelves. THAT is the problem most people are having with this. It is all about money, and insulting the people on this board isn't going to do anything.
I appreciate the fact that Dr. Mintz has allowed this forum to go on, even in the midst of heated discussions. He has said the health care system in this country needs fixing, and I agree with him on that.
So, you can continue to insult the people on the board, or you can look at the real issue, which is that some people do not believe Primatene should have been pulled when there is no affordable over-the-counter medicine to replace it for those who cannot afford to go to the doctor every three months for new prescriptions - prescriptions that cost three times as much sometimes as the Primatene did. It may not have been the perfect, ideal solution, but for many, it was the only solution accessible to them, and it was better than no solution at all.
KEEP YOUR LAWS OFF MY BODY!
If the goal is the protect the consumer from themselves, I say that isn't a good enough reason. In fact, if someone is too lazy or too stupid to read and follow directions, then let them kill themselves. The world doesn't need more stupid people.
Ahh yes, someone who makes their money pushing Big Pharma drugs is telling us "little people" how to live.
I have news for you doctor, albutrol is available in many many places without a scrip, trust me on this.. and Primatene Is not going away any time soon. It will be back and you will continue to try to brainwash the public into thinking its horrifying.
Contrary to what you are telling people here, many used Primatene because it was ALL THAT WORKED. Ive done my time with doctors and drugs, none of them gave me any help whatsoever.
I just came across here from another board. Doctors without asthma who think it's a great idea that primatene inhalers were banned make me very angry. Albuterol does not work for me, I don't know why. I'm a pilot, not an M.D. After primatene was gone I tried the asthma pills but they didn't work well, and were useless in an emergency scenario. There's a new alternative, same ingredient as primatene, with a tiny little nebulizer, asthmanefrin OTC. It has given me my life back. I've used it 30 days now and already lost 13 of the 30 pounds I gained due to inactivity from fear of an attack. Going skiing next week. I still hope for a more pocket-friendly version but primatene being banned was a nightmare for millions. A nightmare. like waking up paralyzed or blind. Shame on you doctor, shame.
Asthmanefrin OTC would be great IF it worked. As soon as it was introduced to our store shelves, we rushed out to buy it, as my husband was tired of practically suffocating daily since the Primatene ban, and we were excited that he might actually be able to take a walk again or do anything active. However, just a few days after buying it, the thing stopped working and does not allow him to inhale the medicine. We had bought it out of state so we couldn't return it to the store, so I wrote to the Asthmanefrin company to let them know I need a replacement, and all I got from them was a bunch of form letters and excuses and a promise to send a "new plastic clasp," which wasn't even the problem (and by the way, they never sent the plastic clasp). The ONLY solution here is to bring Primatene back. But of course, that little $20 life-saver costs far too many pharm companies and docs far too much money...
Thanks Doctor for espousing the "party line" I guess you're just going to ignore the 40+ YEARS that this OTC inhaler has been used safely and effectively, huh? It wasn't banned by the stupid FDA because of side effects, it was banned because the CFC propellant harms the ozone layer. What BS. Lets kill off (death panels, anyone?) the millions that found relief from Primatene Mist so we can save the effing planet. Just stay true to your BigPharma masters so you can keep your medical license. Doctor?....Ha!
Anonymous,
You have obviously not read the many comments on this post or my responses. I agree that the environmental rationale for pulling CFC's is probably a non-issue. However, I feel strongly that epinephrine should not be available over the counter. FDA approved this years ago under different rules. It would likely never be approved today for a prescription medication, let alone for OTC use. The makers of Primatene decided that rather than go through the process of developing an HFA epinephrine product (which they realized was an unwise investment since as I stated the FDA would like re-consider their grandfathered status), the company decided to lobby Congress to get an excemption from the rule that all other albuterol manufacturers had to comply with. They did not succeed.
It would be nice if I could just go to a doctor and get a new prescription for my albuterol every year. But I have no insurance. So I guess I should starve my children, then. Or else just suffer through my asthma attacks. Because I can't really spend $300 to see a doctor once a year just to get one prescription. But hey, at least no one has to worry that I'm running through a prescription faster than a year. That will be a comfort to my family when I'm dead from not being able to afford a doctor visit to get a prescription for a medicine that a mature adult might be able to properly monitor on their own.
Oh shut up.
Seriously.
$9 for a one or two shot medication?
Are you stupid? THAT'S EXPENSIVE!
And that's IF your state or local pharmacy carries it.
This is why Americans are starting to hate all of you.
My husband is severely asthmatic. He's been this way all his life.
He's been getting the same prescription for decades now. The other prescriptions come and go, but ALBUTEROL IS ALWAYS THERE.
ALWAYS.
The UK is selling albuterol OTC, now, and that's in a nation where EVERYONE has health care. This was a decision that the NHS made to cut down on the load of patients hogging up doctors offices for the same old medication they're always going to get, anyway.
It's been that way for a while now and guess what?
IT'S NOT BEING ABUSED!
ASTHMATICS AREN'T DYING IN THE STREETS!
AND THEY'RE STILL GOING TO THE DOCTOR WHEN THEY'RE SUPPOSED TO!
Of course, it helps that they have a health care system that cares more about people than how much money the sick have, and aren't this conglomeration of blood-sucking pigs known as doctors, hospitals, insurance scam artists and pharmacological giants that we have in America.
And you are a freaking nutbag for thinking that taking Tylenol or Aleve off the market would be a good idea.
It wouldn't be.
I tell you what, cupcake: When more people die from taking Tylenol for normal reasons than from the incompetence, negligence and greed of doctors, then you can take Tylenol off the shelf.
I shouldn't have to pay an nutbag like you to get something to relieve a headache or fever.
Ever.
Alright, and I want to respond to another one of your comments above. Apparently you think bronchodilators should not be available over the counter because people do not know they should also be using corticosteroids for treatment ... so the answer is educatin -- not the artificial requirement that they have to see "doctors". What is a doctor? It's just another person who has read some books about the body and then gotten rubber stamped after putting themselves through a 10 year meat grinder. Non-doctors aren't somehow subhuman or unable to comprehend what they themselves need to do. Look, people can get educated if they need to do more than just use a bronchodilator, and it doesn't have to come from a doctor's office. I am sorry to say but your views show a tremendous conformity and desire to cling to a standardized system for no apparent reason. It looks to me like you are primarily concerned with keeping your own notion of self importance and authority maintained, and what you need is a psychologist more than us mild, seasonal asthma sufferers need a doctor.
Its coming back !
According to the makers of Primatene an NDA, new Drug application has been filed with the FDA i n April 2013 for Primatene HFA.
Makers of Primatene have every right to apply for NDA for Primatene HFA. I don't think it will get approved, and certainly not for OTC status.
Mr. Mintz,
What is very bothersome is, that the folks against PMist didn't offer discounted or free office visits, nor did they offer an option at the same cost of PMist. So who benefits from taking PMist off the market?
Physicians and Pharmaceutical companies.
I personally would like to see the data produced that would indicate how dangerous PMist is. How many deaths were related to it. What was other factors of the study.
My husband has suffered greatly. The inhalers are $50-60 a month, they make him nauseous all the
time. For 25 years he used one PMist every 3-5 months (depending on the weather), @ 17.99. He used 200 pumps in less then a month with the prescription he received by the doctor. Every 3 months he has to go back for a "check up". What a hack of crap. Basically per year we have to pay 1000.00 that we didn't have to pay for.
BTW, I lost my job and our insurance. He is self employed and has to pay extra deductible of 3500.00 to be treated,(because of asthma)Add in family deductible of 2500.00, we can't afford it.We only have major medical.
Please explain how it is fair?
Ask yourself how good will you feel if you had to go to the state to get insurance? It is humiliating, the employees are so very rude. They treat you like you are a piece of crap that failed. Only to find out, we don't qualify. I was so hurt and embarrassed by the treatment.
One is not allowed more then one inhaler, and in Iowa, it gets cold. His clogged last winter when we had all roads frozen over, and we had to watch him breathe, as he dropped to his knees. Emergency couldn't get to us, 15 minutes away to a bigger town, but the roads were frozen, many vehicles in ditches.
How would you feel if your children watched you struggle to breathe, in fear of their dad dying? It was very traumatic.
So, please explain how this is a good thing? It has caused nothing but heartache and financial burden to us.
Please email me with any suggestions. Brandi Mastain
blmast@live.com
This was not done for the safety of folks using Primatine Mist.
If it was, then the physicians would of offered a free visit, and an alternative inhaler at the same cost as PMist.
How many people died using PMist? What were other factors? Would like the link to the data (PROOF), that says it is dangerous.
Go and apply for state aid? Embarrassing, and very humbling to find out one doesn't qualify.
Last winter my husbands inhaler clogged, and he dropped to his knees struggling to breathe. See they don't let you have more then one inhaler. It was the day when most of the state was frozen over, and travel impossible.
Can you imagine how traumatic it was for our children to see that?
He used on PMist every 3-5 months, @17.99. Now it cost $50-60 a month plus an office call every 3 months @ $90-120.00
We only have major medical insurance, and it is very costly.
He now uses 200 puffs a month. It's like it backfired on him. Makes him really dependable. He gets so sick to his stomach with the inhaler, and his breath is just horrible.
It's time the victims of this horrible situation stand up and be heard, call those who represent you, or send me your story @ blmast@live.com I intend to hound our representatives, until something is done.
Should last a year huh? And you try taking those horrible steroids, enjoy the leg cramps and irritated throat. Have fun losing your voice and having a constant sore throat. I used to have a Primatene for over 3 months with no issues, now these shit RX things barely last 2 weeks. And cost almost 100 bucks. You try being able to maintain your asthma when the doctors don't listen that they don't help! The side effects from the steroids are terrible, and even if you can suffer through them you still are not gonna get more than a month from the albuterol inhaler. Give me a break.
This original post was rather naive. In order to get a "prescription" for Albuterol a Dr's visit is required which almost always includes several mandatory "tests", "Xrays" etc. The cost of a visit then goes into the unaffordable range when these tests are included. An OTC inhaler is a much needed product when desperate measures are required. Dr's don't really care if you're suffocating only if you can afford their fees and tests.
I am 62 years old and I am proof that you are wrong. If what you are claiming is true, than why are the risks and side-effect almost exactly the same in all drug books? My new nurses manual says, do not use if you have a heart condition. You can't take it with Beta-Blockers and other drugs like antidepressants.
I was diagnosed with asthma at age 15, put on steroid shots until I couldn't tolerate them any more, put on asthmacort, bad reaction, tried Albuterol, which actually gave me asthma. Levalbuteral, same thing. Tried herbs, teas and other natural, hollistic treatments and they did nothing to help.
I've used Primatene Mist and then Asthmanefrin for over 44 years. I started Singulair about 8 years ago, which helps but doesn't help stop an asthma attack. I need a rescue inhaler in order to live! Following your advice almost killed me when I went camping and didn't realize my new inhaler was a Beta II Agonist (Albuterol). What no one is considering is the fact that some people can't tolerate Beta II Agonists or Steroids, especially when you have used them for years. They have horrible side effects.
My lungs, heart and physical condition is great. My doctor tells me that your advice is wrong. People with my kind of asthma, that is managed without steroids, should not take steroids. It's overkill! I'm healthy using Epinephrine (adrenaline) because I don't abuse it. People abuse prescription drugs all the time also. You can't control that. Not being able to breathe is a health hazzard. Your advice will cause the only other rescue inhaler (Asthmanefrin, Racepiphrine)to be banned by the FDA.
They have already recalled the Atonomizer used with it, for a reason that should take all nebulizers off the shelves. I know for sure that many people will die, like me and others that can't afford insurance, or someone whose inhaler doesn't work and they can't breathe if they discontinue this lifesaving inhaler.
Please consider that some people can't tolerate Albuterol products! Everyone is different. Give us a choice. Breathing is a matter of life or death. Not being able to breathe can kill you very quickly! It's not an arthritis drug! It saves lives all the time and has been used for many, many years.
Ms. Nelson,
There are two issues with Primatene. First, that for 99.9% of asthmatics, albuterol works just as well. Second, that it is over the counter, and I believe too dangerous to use without physician supervision. I am all about choice, and if the FDA approved this for those few patients who needed epinephrine instead of albuterol, I would have no problem with that. However, I do not think any asthma rescue medicine should be over the counter.
Since you think the Asthmanefrin (Racepinephrine) rescue inhaler should not be available over-the-counter, do you also think the FDA should take Tylenol off the shelves too? It can ruin your liver if you take too much. Do you really think you are saving more people than you are helping by getting a prescription of Tylenol? These people taking tylenol need to know why they are in pain. Maybe they really need to get to a specialist and be given Oxycontin with a prescription. Ridiculous.
I am emotionally charged about this because my long time friend died in her sleep 2 years ago, from her asthma, when Idaho was engulfed with forest fires. What a tragedy! And I have already suffered a lot because of this ridiculous position many doctors are taking that "is" influencing the FDA. They make their position very clear. They want to get rid of Adrenaline type rescue inhalers, especially over-the-counter, because they want asthmatics to get to a doctor and get on steroids. Most doctors still think that Adrenaline is WAY more dangerous than Beta II Agonists. They are wrong. They have decided that my death isn't important because it will save more lives to take this life saving RESCUE inhaler off the market. They are ASSUMING.
While I don't think Tylenol should be removed from the shelves, I will tell you it would never be approved by the FDA using today's standards. The difference is that Tylenol is used to treat acute pain, and asthma is a chronic disease. I am sorry that your friend died; however, this is precisely why I am concerned. Managing asthma with over the counter beta agonists without the supervision of a physician could lead to over-use, under treated asthma and even asthma death.
My friend "was" being treated for her asthma by a doctor, for many years. She used Albuterol and was on steroids.
Are you against all over-the-counter medications and hollistic treatments? What if people take the whole box of pills? Do you have the actual statistics on that? It is a fact that more people die from PRESCRIPTION medications than all the other drugs put together. I used to work at the community health center. Prescription drug overdoses are a huge problem in the U.S.
And also, most doctors are promoting steroids, saying, the new steroid inhalers don't get into your system. It targets the lungs. They told me they are very safe. These inhalers came out in the 1980's and was thought to be VERY safe but now we know different. And after-the-fact "I" found out, my old doctors were wrong; steroid therapy WAS overkill, for treating my type of asthma.
After, I had already been on Steroids for 17 years and having SEVERE problems, I was put on Asmacort. It gave me severe depression and anxiety with massive headaches. I became so weak that I couldn't stand up straight. I had thrush in my mouth, among many other side effects, like rattling in my lungs. It hurt to breathe. I kept getting sick. My immunity was weakened. Doctors, in 1986, told me Asmacort can NOT do that. I was put on an antidepressant and continued to get worse because I had TOO much faith in my doctors. I am not exaggerating!
I understand that you think epinephrine rescue inhalers should be available in a prescription, for the 0.1% that you assume can't tolerate Beta II Agonists. So far, that has not happened. Why is now different? And you had a completely different opinion in 2008, stating Primatene Mist was too dangerous to use at all. Since when were doctors experts on drugs anyway? Doctors have decided that my death is not important because taking my drug off the market saves more lives. Doctors could not possibly have the real statistics on this. It will and already has cost "more" lives since 2011.
What about all the nights I almost died and was saved by Primatene Mist, especially years ago, when I was living in poverty? Or times like, 3 weeks ago, at 10:30 p.m., when my atonomizer, that I need to dispense the Asthmanefrin (racepineprine), stopped working and I couldn't get another one at Walmart or Walgreens because it's been banned by the FDA? I was up until 5 a.m., trying to breathe, until I rubberbanded an old broken top part to the bottom of the newer one that still worked. Then what? I am in deep trouble.
How could THESE occurances possibly be included in your statistics?
Saphrona Nelson said...
Now days, standard asthma care requires using drugs that they say treat the disease with these type of prescriptions:
Millions of people with asthma, including many children, have gone on the drug and Advair sales have exceeded $4 billion every year since 2007.
Yet medical studies, independent doctors and court records indicate the drug can be dangerous, especially to children, and has been massively overused and often inappropriately prescribed.
Advair and other drugs that contain long-acting beta-agonists have been linked to 1,900 asthma deaths from 2004 through 2011, according to an estimate by AdverseEvents Inc., a private firm that analyzes incidents reported to the U.S. Food and Drug Administration. The incident reporting system is voluntary, so the estimate likely is low.
In a different analysis in 2008, an FDA researcher estimated the drugs contributed to 14,000 asthma deaths from 1994 through 2007. Advair, approved in 2000, is by far the biggest seller.
These types of "dangerous" drugs are given through a doctors care, written with a prescription. The FDA recently rejected the new Primatene Mist HFA inhaler because it's a hazzard to your health. They wrote, "you need to treat the disease".
Asthma is NOT a disease like arthritis or heart disease. It's more like having an extreme allergy to peanuts. Without a quick reacting antidote, you could easily die in an instant. Not being able to breathe is a killer. People without asthma don't understand that. Taking away the only drug that quickly relieves an asthma attack, and causing an asthmatic to suffocate, is cruel.
June 24, 2015 at 5:42 PM
@Saphrona Nelson- you are misquoting statistics and attributing them to the FDA.
Advair has not contributed to one single death. The one study that the LABA safety issue is based on is a controversial study that shows LABA's used without an inhaled corticosteroid are very dangerous. The same "asthma death"study showed that ICS protected patients from asthma deaths and no patient on Advair or the equivalent died in the study. However, because the study was not specifically designed to address the safety of ICS/LABA combo, the FDA continues to mandate the warning. The study that is designed to answer the question is being conducted in nearly a quarter million patients and the results should be out in 2017. Any expert will tell you that the all the LABA risk is due to taking a bronchodilator without an ICS. Similarly, short acting bronchodilators (SABA's) should only be used rarely, and used frequently MUST be taken with an ICS to prevent hospitalization and even death. The difference between LABA's and Primatene, are LABA's are by prescription only. Primatene is an over the counter SABA, and my entire issue is that I am concerned patients will use it inappropriately, taking it more than safe without a prescription ICS inhaler.
Your "entire issue" is that you are NOT listening to the people who are obviously still alive and used Primatene safely for years before it was snatched away from them. Your entire issue is that you, like most in the medical industry, stand to lose a lot of money if people are given the option to treat themselves. You may very well care about people and want to help, and you may very well be concerned by the misuse or overuse of products, but you nor anyone should have the authority to tell anyone that they are not allowed to treat their own sickness in their own body in the way that they feel is best for them. Of course, if you allow people to make their own decisions about their health, you and Big Pharm and Big Insurance and even the feds via Obamacare stand to lose a lot of pocket change. All things considered, the fact that Primatene is not readily available makes it VERY clear that the FDA and Big Med are more concerned about the dead presidents in their pocket than the dead people who might have lived if they'd had reasonable and affordable access to a rescue inhaler without having to get your signed permission slip for them to breathe.
@autiej
1. Regarding this particular issue, no primary care physician including myself, will lose 1 penny is Primatene mist went back OTC. We have a crisis in primary care access. Some patients are still without insurance, and even those that have it can't get access to a PCP because there are so few of them and they are booked up for months. While your argument may be true for other meds (Nexium OTC might be one good example) physician greed is not applicable in the case of Primatene.
2. You are essentially saying that once a drug is approved by the FDA, then patients should be able to access it without a prescription. We will never agree on this. There is a reason why it takes 4 years of medical school and at least 3 years of residency to prescribe something for a patient.
3. "Your" issue is cost and access. Because Primatene was OTC, patients without insurance could get it and not have to see a doctor. Access and coverage is a HUGE problem. Cost of some prescription medications is a HUGE problem. I would like every American to have access to a good primary care physician and good medications and be able to easily afford both. Two wrongs simply don't make a right. You don't allow unlimited patient access to a potentially dangerous medicine because they can't afford to see a doctor. You figure out a way for them to see a doctor and afford better medicines.
"You don't allow a patient access to a potentially dangerous medicine because they can't afford to see a doctor." Hmm. There are medications and foods and toxic items like cigarettes and alcohol and every other such thing out there that you have allowed. An inability to breathe is an instant and potentially fatal desperation, and the medical industry DOES capitalize on it. "No physician will lose 1 penny." Right. Because you don't charge 1 penny for people to come to the office. You get lots of pennies, from the patient or insurance. It is very big business to knowingly deprive people of breath, my friend. And it is also about as unethical as anyone could get. Aspirin and Pepto Bismol can kill someone if misused, yet I can buy them in a gas station. The difference is that a minor headache or a tummy ache won't have someone running to you fearing for their life. The very fact that deprivation of breath is potentially fatal ensures that LOTS of pennies are made by the gatekeepers, and, like it or not, YOU are a gatekeeper. The very fact that you wave your medical degrees around like Willy Wonka's golden ticket in your responses here and use the term "allow," as if you have ANY right to tell ANY other human being what they are ALLOWED to take for their health proves my point. Respond again. You'll only prove me right. The existence of this blog proves that Big Med is in it for the dollars, because if you weren't (and you ARE a cog in that giant tyrant of a wheel) you would LISTEN to what people are saying here. What if someone told you that you had no right to decide for yourself what climate to live in or what foods you eat? What if someone did not "allow" YOU to make decisions for your own body, regardless of your medical degree? You get away with saying things like this because you with to almighty medical school, but my lungs are mine and the lungs of the people here are theirs, and MANY of the people here have used Primatene for years - even decades - and their fathers/mothers before them, and suddenly, they don't have that option. It is THEIR OPTION, NOT YOURS because the last time I checked, even a medical degree is not a deed to everyone else's body parts.
@autieJ I know you are upset about this because your husband has bad asthma and used to be able to get Primatene. (I have previously offered to assist you in finding access to physicians and medicines because options do exist-though not always easy).
It's interesting that you use cigarettes as an example. I wish no one had access to them.
Alcohol is also interesting. While prohibition didn't work, and I enjoy a beer on occasion like most Americans, and would be annoyed if were made more difficult to get, alcohol and alcoholism are responsible for more death and disease than all other recreational drugs combined.
Pepto Bismol is extremely safe. Asprin is probably safe enough to be over the counter. There is absolutely no way that Primate Mist would ever be approved as a prescription drug by today's FDA standards, let alone be available as an over the counter medication. The only reason it remained available over the counter because it was approved a long time ago under much less stringent criteria. Once that happens, there has to be enough evidence of serious harm to pull something. Primatene definitely showed, but never reached that threshold. It was pulled from the market because of the environmental ban on CFC's (I will not argue this point as I don't see why an exemption couldn't have been made for all inhalers). The company that made Primatene COULD have decided to make a CFC free Primtene mist (all the other companies that made albuterol did this), but chose not to. Thus, it wasn't greedy doctors or even Big Pharma that was responsible. It was one of the smaller drug companies that made a business decision that it would be better off not to make a newer version of an unsafe medication that wouldn't likely be approved by the FDA anyway.
Some medications are appropriate for over the counter use. Some are not. Some should be used only with the guidance of a physician. I believe that Primatene and albuterol fall into the later category. If your husband suffers because he does not have access to good medications, I truly do feel bad for you and once again offer my support if there is anything I can do to help. However, I will not change my position about a medicine that I think is overall dangerous to use without a prescription especially when other (prescription) versions are available and have fewer side effects.
I no longer have the husband, though I'm sure he still has asthma and still has to find a way to deal with it in a country where illness is big business. I was only using cigarettes as an example to indicate that what the government allows (and yes, the FDA IS the government) does not always equate what is healthy or not. I have not even claimed that Primatene is safe. I have simply said that nearly everything can be dangerous if misused or overused. I do not want you to feel bad for me. I want Big Med to stop treating people like livestock and let them make decisions for themselves. I do not have asthma any longer, though I did when I was younger, and if it was not for Primatene, I would have been in the ER every weekend. How nice that would have been for the hospital and doctors who profited from such visits - and now it's quite handy that those visits are increased because no one can get their hands on medication that will help them in an emergency without a permission ship from you or your cohorts. The FDA is NOT the owner of human beings, and they should not have the authority to make these inds of decisions. The "smaller drug company" that had to give up on Primatene was bullied out of producing it; as you said, "they knew it wouldn't likely be approved by the FDA anyway," and do not try to tell me that the FDA does not work hand in hand with the medical INDUSTRY (which is sadly what it is) to control things in a way that will ensure profits starting with office call costs and ending with costly prescriptions and then more office calls and more prescriptions to treat the side effects. Every time someone steps foot in a doctor's office, that doctor will make money. If you can force them to step foot in there to get an emergency inhaler, you will make all those pennies you claim no one makes. Just as you will not change your position, I will not change mine. The FDA does not own human beings or their body parts, and them, you, nor anyone else should be "allowed" to tell people that they cannot use medicine that will help them, even if there are risks associated with it. Adult human beings should be able to decide this for themselves. Contrary to Big Med belief, we are not all just dumb sheep who need to be led around by the nose, and we CAN and should be "allowed" to make decisions for our own selves and weigh the risks and benefits for ourselves. Insurance should be disbanded, and medications that thousands of people used for countless years should be left on the shelves. Cars kill people every day. Maybe the FDA should disallow those too. Clearly, none of us are capable of deciding for ourselves if we should use them or not. It boils down to the fact that when someone can fix their own car, the mechanic goes out of business. Big Med doesn't want to go out of business, and asthma is BIG business. I will not comment again, because there is obviously no point. It just sickens me that you and your colleagues and the bureaucratic, greedy bureaus and associations and administrations would stoop to not letting human beings choose for themselves, especially a medicine that was around for many, many years and saved more lives than it took. The FDA approves things every day that will literally kill and addict people. Tell me, who is telling THEM what they're "allowed" to do? You will hear no more for me, because the medical industry doesn't listen anyway. After all, we're stupid sheep who can make no decisions for ourselves, so why should you listen to our baa-ing?
We are simply not going to disagree here, because at the core of your question is the role of government, and to some extent business, in regulating what people do. This blog is meant to help patients with diseases and not a political forum.
Thus, I will only respond to this one sentence:
"Especially a medicine that was around for many, many years and saved more lives than it took."
I would be open to any proof or support of this statement. It is simply not true. While you state that Primatene kept you out of the Emergency Room, I contend (and have some data to back this up) that Primatene actually led to more Emergency Room visits. Not because Primatene per se is dangerous, but because patients were trying to manage asthma on their own, and got into trouble.
Dr. Mintz, What you wrote about Advair is just not true. It doesn't make sense to assume that LABA (Long Acting Beta Agonists) are safe with a steroid. There is no evidence of that at all. I think you have been mesmerized by GlaxoSmithKline, after getting on the band wagon of this hugely profitable drug. Doctors like you are scary. It's as if you have turned into a pod-person from "Invasion Of The Body Snatchers". Big money speaks loud and clear.
Actually, it makes complete sense to assume that LABA's are safe with steroids, because every study that has looked at ICS+LABA have shown they are better than ICS alone, double ICS dose and even ICS+ montelukast. However, one does not need to assume. In the SMART study which raised the safety concern, the patients who were on ICS had no problems with LABA. All the dangerous problems occurred in patients taking the LABA without an ICS. All the scary warnings about Advair and similar drugs boils down to politics and an academic argument, that since the study wasn't specifically designed to show ICS + LABA's were safe, even though they were shown to be safe, you can't 100% say they are safe. The study that is specifically designed to answer the question is currently being done and involves over 250,000 patients. Results should be out in 2017. In the meantime, the preponderance of the evidence shows that ICS + LABA is safe.
I've read stories all over the internet about deaths from Advair, who have sued GlaxoSmithKline and settled out of court. Some people can not tolerate the LABA with or without the steroid. There is a problem with over prescribing, assuming this drug is safe for all patients because it is using a known dangerous drug, LABA (Long Acting Beta II Agonist) with a steroid. There is NO evidence to date proving it is safe.
The data from the SMART trial are not adequate to determine whether concurrent use of inhaled corticosteroids, such as fluticasone propionate, the other active ingredient in Advair HFA, or other long-term asthma control therapy mitigates the risk of asthma-related death.
Table 1. Asthma-Related Deaths in the 28-Week Salmeterol Multi-center Asthma Research Trial (SMART)
Fernando Martinez, MD, an asthma specialist at the University of Arizona, and other researchers say the problem stems from the hundreds of thousands of people with mild asthma who should first be put on just an inhaled corticosteroid, but instead are started out on combination products such as Advair.
"I think these medicines do cause an improvement, particularly a subjective improvement, in everyday symptoms," Martinez said.
But while the drugs may be improving everyday symptoms, they may be producing unnoticeable physiological changes in the lungs that make the user more susceptible to a severe asthma attack, said Shelley Salpeter, MD, a California doctor who has researched the danger of the drugs.
No one in the SMART study who died was on Advair.
I am not aware of one case where it was proven that Advair killed a patient.
Please do not use lawyer ads on TV as a source. These ads come from greedy lawyers who file class action suits the second one possible side effect of a drug is suspected. Drug companies (who are beholden to their stockholders) often settle some of these claims as a financial decision. In other words, just because there are ads on TV, and even if a company settles as a cost of doing business, do not assume a drug is dangerous. Avandia is a great example. There was much hullaballoo about a study which potentially showed Avandia caused heart attacks, many ads on TV, settlements by the drug company. In the end, the FDA determined that Avandia actually doesn't cause heart attacks. (The Advandia fear mongering led to millions of dollars of unnecessary research, delays in good new drugs for diabetics, worsening of diabetes for patients who stopped Avandia, and increased need for insulin in diabetic patients).
And yes, there is research that shows LABA's are safe with ICS.
Here's one of the better studies
http://annals.org/article.aspx?articleid=741442
I'm sorry, not buying any of it. I used Primatene Mist for many years, which worked wonderfully for my occasional asthma, caused by allergies which "wax and wane", meaning, I sometimes go months on end between attacks. So why would I ever voluntarily agree to pump my body full of cortisteroids on a daily basis? That's ludicrous.
Yes, I have insurance. No, it doesn't cover the outrageous cost of Albuterol. It has, however, paid thousands of dollars to the allergist I was forced to resort to after Primatene was taken off the market. He insisted on running one useless test after another, all of which came back negative (probably because my allergies were currently waning), until I realized all he was accomplishing, was to generate revenue for his practice. I finally walked out, and never went back. Fortunately, my husband has an Albuterol prescription. Doesn't work anywhere near as well as Primatene. Not even close.
Of course, the only reason my husband has severe breathing problems is because his lungs are permanently scarred as a result of Steven Johnson Syndrome (SJS) - a severe reaction to Lisinopril, his cardiologist prescribed blood pressure medication!
Don't even try lecturing me about all the tests that supposedly prove Lisinopril isn't dangerous, or any nonsense about the importance of physician monitoring. My husband's doctor kept him on Lisinopril for 3 years, not only ignoring, but even ridiculing his escalating complaints. Especially, when he started feeling as if he was simultaneously both burning and freezing...because he was! As SJS started burnt his throat and lungs, Toxic Epidermal Necrosis kicked in, frying his skin cells. Skin keeps the body warm by holding in heat, so as his died and fell off, he was literally freezing to death, while burning alive.
As his skin died, it cracked, damaging and infecting the underlying tissue, which then proceeded to puff up like a balloon, oozing pus and blood, all of which his dermatologist initially claimed was a combination of eczema and psoriasis. Combined with the severe pain as his breathing and swallowing grew ever more difficult, it was terrifying.
It wasn't until his body temperature dropped below 90 degrees that he was hospitalized, telling us they suspected a flesh eating bacteria or toxins from his job site. They never once even considered Lisinopril a possibility, and continued giving it to him in the hospital for another 4 days before the only doctor qualified to diagnose his condition was able to look at him. In the meantime, he deteriorated so rapidly, we prepared for his almost certain death.
The reason it took that long is because that particular doctor only worked in the 2nd floor, and apparently, was way too busy to take a 30 second elevator ride to my dying husband's 1st floor room. It was 4 days before a 2nd floor bed opened up, and the doctor finally moseyed on over. I don't think it took him more than a minute to look at my husband and glance at his chart before telling his cardiologist "No more Lisinopril!"
Just the greedy lawyers, huh? My husband suffered extreme agony, almost died, and is now permanently disabled. At 145/100, his BP was never even that high to begin with! On the positive side, homebound, he's had lots of time to learn how to cook everything from scratch, salt free. Won't fix the permanent damage to his skin, heart or lungs, but at least now his BP's super low!
Please don't bother telling me how very rare SJS is, because although both
Tylenol and Advil are listed as 2 of the roughly 100 drugs that carry the risk of SJS, Lisinopril isn't. In fact, at least as of the time my husband contracted SJS, it didn't even have a black box warning label.
So why not tell me more about those greedy lawyers, and where I can find one?
My mom used Primatine Mist for over 20 years . The constant use of a OTC inhaler proved dangerous for her. Epinephrine if used long term causes damage to the heart muscle itself Also to put your body into fight or flight mode every time you use it which wears the pancreas out and decreases the bodies ability to make insulin .... Causing Diabetes . So in a nut shell this OTC medication caused my mom to have Cardiomyopathy and Diabetes. Which killed her in 2012. If she had just gone to see the Doctor instead of taking this OTC killer ..She might still be with me today ..
My mom used Primatine Mist for over 20 years . The constant use of a OTC inhaler proved dangerous for her. Epinephrine if used long term causes damage to the heart muscle itself Also to put your body into fight or flight mode every time you use it which wears the pancreas out and decreases the bodies ability to make insulin .... Causing Diabetes . So in a nut shell this OTC medication caused my mom to have Cardiomyopathy and Diabetes. Which killed her in 2012. If she had just gone to see the Doctor instead of taking this OTC killer ..She might still be with me today ..
Dr. Mintz.. it's been over five years since you wrote this piece and STILL you are getting angry asthma sufferers commenting. That is practically unheard of in the catalog of internet blog articles. The reason is pretty obvious... there is still no decent OTC replacement for Primatene Mist. There ie Asthmanefrin, which works just fine, but is extremely inconvenient and expensive.
I have suffered from asthma to some degree or another since I was a young child. I was an Alupent user for many many years, and albuterol almost killed me more than once. I also used prednisone, ventolin, intal (cromolyn sodium?), and theophellin. I had very good access to medical care, but had an older doctor who was uninformed and obviously not doing a great deal of continuing education. He put me on theophellin but failed to routinely check my blood levels to adjust my dosage, and as you are probably aware, there is a very fine line between the therapeutic dosage and the toxic dosage. Between the age of 6 and 19, I found myself in the hospital halfway through springtime 5 or 6 times for a week each. At some point the albuterol would just stop working, but as suffocating child I would just keep sucking away at it. Usually my hospital stay began with a trip to the emergency room and the first thing they did was give me epinephrine injections.
For the most part, my asthma is entirely related to my allergies, and once spring is over, it subsides. But it never fully went away because I never actually learned that my breathing behavior was wrong, until I was about 19. When I finally learned how to not breathe shallow, it changed my entire life, except for springtime.
Now, the ONLY time I ever need any medicine is during a bad allergy season, when I wake up unable to breathe. This occurs maybe 2 to 4 times a year at the most. With that said, you will have to excuse me for being very offended by the arrogance of your profession. Physicians did not always properly manage my asthma. NEVER, did any of them address my shallow breathing behavior. The medicines they prescribed me, almost killed me.
The medical profession should consider its best practices as just that, best practices, and discourage government regulation. IT is my body, and it is MY RIGHT to decide what I want to put into it, for what reason, based on what is available, what the costs are, what the risks are, and other such factors. I am a reasonably informed consumer, and this year I am a VERY pissed off asthma sufferer. Though I appreciate that your knowledge is superior, and that you are looking out for the best interests of the population as a whole, I really resent your arrogance in thinking you or anyone else should be making this decision for me. The same applies to the pseudoephedrine issue. I get 1 claritin D per day, and if I lose one, well, then I have to go without.
There is a big difference between educating people and promoting best practices, and getting between someone and a product that helps them and is convenient to obtain. I think if you found yourself unable to breathe you might feel a little differently on this issue.
Dr. Mintz,
Do YOU have asthma? I DO! And I know what works for MY body. I used Primatene safely for years.Despite what you say, albuterol DOES NOT work anywhere near as well. I used to be able to jog/exercise and lead a mostly normal life with the use of OTC Primatene. Now I don't think I could run for half a mile. How is that an improvement??!! I am always suspicious of those who suggest something in which they will personally benefit from financially. If there is no OTC asthma spray, then guess what? One has to go to you (and pay $$$ for an office visit)to get a script. So, YOU gain financially. WHy aren't you crusading about getting cigarettes off the market? I guess smokers bring you "healthy" (pun intended) profits, huh? Breathing is NOT optional! It's amazing that I have to tell a doctor that! Doctor Mintz, do me a favor. Take a straw and put it in your mouth. Leave it there for a day and breath only through that. Tell us how you feel at the end of the day. Oh yes, don't forget to exercise!! As you can tell, I am disgusted as to what the medical profession has come to in this country. It's all about money and not the patient's health. I could write more, but I can feel my blood pressure rising. That would require me to pay for anther office visit and script, so I'd better stop. Thanks for listening.
I agree with Anonymous. I have a Nursing Spectrum Drug Handbook and many other drug books since 1991. The side-effects of Primatene Mist (ephinephrine) are very similar but Albuterol products (beta 2 adrenergic agonists) have the added risk of "paradoxical brochospasm", which I did get and almost suffocated while camping because I didn't realize this new, prescription inhaler, Albuterol, could cause an asthma attack, worse than I had had for many years.
I didn't realize it was not epinephrine. It is very different. Even though I have great insurance, I was just out of luck, because you can't get epinephrine inhalers, even with insurance. They provide no choice at all. It's inhumane! I am very upset about this.
I really think doctors and one-sided thinking, health officials have decided something that is very wrong. FDA panelist, Dr. Bradual Chowdhury, influenced and voted against the new HFA Primatene Mist for reasons that were unsatisfactory. It's so sad that no one in charge is really listening or cares about the aftermath of this reckless decision.
Saphrona, thank you for your agreement. Dr. Mintz, here is something else to ponder. When Primatene was taken off the market, the reason (more accurately "excuse") given was that it harmed the ozone. OK, fine. But that begs the question again, why are cigarettes allowed to be sold?? Look at the smoke, pollution and who knows what other harmful substance they produce. But I guess that is OK according to the almighty AMA & FDA! Sicker people = higher income for doctors & hospitals. Sadly that seems to be what the AMA is about. OK, so a CFC free version of Primatene was proposed by the manufacturer. But the powers that be SHOT IT DOWN!! Now we know the real reason it was pulled! It was NOT ozone, but the removal of a medication that worked so people would have no choice but to go to a doctor and pay for a visit and script for an inferior product. It is amazing that in this country there is NO OTC quick acting medication for something as essential as breathing. Absolutely incredible! We are truly becoming a nanny state. You are invited to respond doctor.
Anonymous, thank you also. It's wonderful to find validation about this in a busy world that does not understand. I agree. It wasn't about the CFCs. Other things are producing more pollution to the air. In our city, diesel trucks are not required to get an emissions test. What's that about? I get behind one of these trucks and it triggers an attack. City officials on the Health Board are trying to fight against the test in the face of evidence of how polluting they really are. Now Primatene Mist is trying to get their new and improved HFA version approved by the FDA again and we have to wait another year to find out the results. Some of these Doctors are fighting every step of the way. When I try and find out why, it doesn't add up. Even my doctor said it really doesn't. They are so worried about side effects and drug addicts buying this product, when asthma attacks kill lots of people, that don't have a rescue inhaler. This is a real life-saving device. It has saved me many times when I was young, low income and raising a family. My lungs are very healthy after using epinephrine to breathe almost every night for about 49 years. I am 63, my blood pressue is low and my lungs are excellent and I really am very healthy. And Albuterol products trigger asthma and don't work for some people like me. It's like these experts can't understand that or even believe it.
Hi Saphrona,
I feel for you as I know what you are going through. I was at Wal-Mart today and notice that Asthma Nefrin is also no longer sold. While this wasn't as good, inexpensive, or as convenient as Primatene, it was better than albuterol. I inherited allergic and exercise induced asthma from my mother. With Primatene and Intal (another discontinued drug that worked very well) I could exercise and lead a relatively normal life. Since they are no more, and for the first time in my life I am on a blood pressure medicine, metformin, and a statin. Of course the doctor tells me to exercise. I have to grit my teeth when I hear that because that has been taken away from me. So how am I healthier now? The doctors, who sometimes act as if they were a god, tell me albuterol works and is safer. Ironically I see NO effort by the AMA calling for it to be available OTC. That would result in less office visits. Can't have that! - $$$. I agree to a point with Dr Mintz in that asthma should be treated by a physician. That is fine in a perfect world. The realty is many can't afford even the co-pay (if they even have insurance), plus there are various types and severities of asthma. Some may need an inhaler only occasionally or seasonally. Why should they have to make an appointment take time off work, and pay for an office visit? PLUS, it often takes weeks to get an appointment, especially with a specialist. That is not good when one is suffering from asthma. The same argument could be made for aspirin/ibuprofin/tylenol. Should one in pain always be treated by a physician? For chronic pain, yes. For the occasional ache etc. of course not. Thus OTC drugs are available. Not so for asthma. Maybe I'd better keep my mouth shut as the AMA may want to pull aspirin off the shelves next.
Anonymous, Thank you so much! I am so sorry asthma prevents you from exercising! I am lucky that usually I can exercise. I have allergic asthma also and many things set it off but it's at night when I usually get an attack. My doctor said it's because the ozone lowers at night to way more unhealthy levels. Pollution can set it off any time. I got asthma for the first time, at age 14, after taking an old school bus to school for 3 years. I remember smelling the fumes everyday, coming from the floor boards. The doctor put me on steroids back then and many years later, I had a horrible reaction. I gave it another chance and the same thing happened and was never able to tolerate steroids again. Ironically, my asthma got better and I became healthier also. Mr. Mintz is also a big supporter of steroids, namely Advair.
I also use Asthmanefrin. It is saving my life now. Very expensive and inconvient to use especially now that the atonimizer was pulled off the shelves by the FDA. I also use Singulair, which has helped me so much but doesn't prevent my night time attacks!
And Dr. Mintz said he wants to take drugs like tylenol off the shelfs also. These doctors force everyone into submission one way or another deciding those that are careless and hurt themselves with over-the-counter drugs, who might also drink rubbing alcohol, are more important than the many who suffer because they don't have access to life saving drugs and can't afford to go to the emergency for asthma attacks or headaches. Makes no sense!
Hi Saphrona, I hope you are doing better. I have also been looking for AsthmaNefrin but hadn't seen it in a while. However, yesterday I was at the local WalMart and saw ONE box left. I greedily grabbed it, almost feeling like I was grabbing an illegal drug. I suppose if some doctors had their way it would be illegal. Incredulously one can go to several states and buy pot "over the counter" as it were. What is the purpose of that drug? Basically to get high or "feel good." Yet something so helpful to living a normal life like Primatene Mist is unavailable anywhere.What a screwed up country we live in, so controlled by medical interests in pursuing their ever increasing profits. Sadly, we are no longer "patients" but profit centers for the medical establishment. This brings up a question: even doctors would have to admit that asthma rates are increasing despite the so called "superior" (i.e. more expensive) drugs. Why is the medical community failing at reducing asthma rates and what is it doing about it? Something obviously isn't working! Sadly, having health insurance doesn't mean health care. My former employer's "health" plan was so bad it wouldn't qualify for Obamacare. Many people have no insurance, and even if they did couldn't afford medical costs. Thus all the more need for an OTC asthma inhaler that works. Dr. Mintz, I have another question. How would you feel if auto dealers tried to pull all auto parts off the shelves, telling us that one shouldn't work on their own cars but only bring our cars to them to be worked on - at jacked up rates of course? I think you would be upset. Likewise with us who suffer from asthma. It's no fun having tightness in one's chest all day knowing that an inhaler existed that helped tremendously but is now unavailable due to the nanny-state FDA and AMA. Tell me again how much better we are supposedly doing? I'll try to remember that through my wheezing... BTW, I am on albuterol and a steroid inhaler, but it is no where as effective as Primatene and Intal used to be. You also mentioned that one's asthma should be managed. I agree to a point. But if you have been to a doctor in the past few years you know that they spend maybe 5 minutes with you, have the nurse type in a script and leave. Another reason we need more OTC alternatives.
We have major problems in our health care system. If everyone had reasonably priced insurance, had good access to physicians, and paid a reasonable/affordable price for medications; no one would be asking for OTC asthma inhalers. I completely understand this, and am sensitive to the fact that for many Americans who have asthma, OTC Primatene Mist was a workaround to our health care system's problems. However, rescue medication use (whether it be Primatene or Albuterol) is the single best predictor of asthma exacerbations, asthma hospitalizations and asthma death. I therefore believe that it should be monitored and prescribed by physicians. While ultimately patients decide what they put in their body, only medications that are extremely safe and would cause little harm should be available over the counter. In my opinion, rescue beta agonists do not fall into this category. Should blood pressure medicines be over the counter? Narcotics? Two wrongs do not make a right. We should do what we can to fix the health care system and have affordable access to quality health care and medications (so whoever's side you are on, please go and vote). You can criticize me for being greedy because a prescription requires a doctor's visit for which we are being reimbursed. I can tell you that primary care physicians are not making tons more money because Primatene Mist is off the shelves. Also, the makers of Primatene Mist could have easily chosen to go through the same process that all the other companies that made albuterol did, which is to make a CFC free Primatene mist and do the studies required by the FDA. They chose not to do these studies for business reasons, because they thought they would be able to persuade legislators to give them an exemption. They were wrong. If anyone was greedy, it was the makers of Primatene.
http://www.drugstorenews.com/article/fda-advisory-committees-turn-down-primatene-hfa-application-otc-status
Dr. Mintz: Primatene Mist HFA did come out with their new product in 2014 and the FDA rejected it. saying it wasn't safe. That is a contradiction to why they said Primatene Mist CFC was a danger to the ozone, stating that epinephrine had been approved as safe for over-the-counter. It's really frustrating when doctors side with these so-called experts deciding for us that no, it isn't safe.
Have you heard of Naprosyn,(Alieve)the anti-inflammatory drug that used to be prescription only, over-the-counter, that comes with some heart risks? This drug has helped so many people that counldn't afford to go to the doctor or have insurance to pay the huge price when getting it through a prescription. Blood pressue medication is not comparable to a rescue inhaler! This is a life saving device that was invented over a hundred years ago, saving many people from suffocation and death. People aren't as stupid as you think. How many more people have died when Primatene Mist was available compared to before and after it wasn't? I have used epinephrine for many years. I am very healthy and have never ended up in the emergency from using it unlike having asthma and not being able to breathe. Albuterol gives me asthma; it does.
You are blaming this on the makers of Primatene Mist? Who is really behind this? I can give one name that is doing everything in his power to stop the new Primatene Mist HFA inhaler from being approved again this year. He is the Pulumonary Physician expert at the FDA, Bradul Chowdhury. Put the new Primatene Mist HFA rescue inhaler on the shelves. People are suffering and dying without it. Does that matter?
My daughter is very allergic to eggs. She will die if she can't get Benedryl in her system quickly. This is no different! When we didn't know what was going on, we got some from the store and it saved her from probable brain damage, because her airway was blocked off, before we could get her to the hospital. Primatene Mist helped her also. You are comparing this to buying narcotics over-the-counter? Does not compare in the least. And don't forget about alcohol. How many people does alcohol kill and hurt?
@Saphrona Nelson. First, lets take your examples of Alleve and Benadryl. Both are safe drugs that unless seriously abused will not cause harm. The cardiovascular risks of Naprosyn are questionable, and even if real, the increased risk is very low. Benadryl is extremely safe. Neither need monitoring from a physician. In contrast, over use of any rescue asthma inhaler is highly correlated with bad outcomes such as hospitalization and death. This is why I think they need to be monitored. Armstrong pharmaceuticals, who make Primatene, initially decided not to go with doing the studies for its HFA formulation in hopes that it would get a "pass" on the new rule. It wasn't until years later, when there product was no longer going to be available, that they decided to make Primatene HFA. I am not opposed to Primatene HFA as a prescription, since as your own experience, not every asthmatic responds as well to albuterol as they do to Primatene. However, the FDA did not approve this because Armstrong wanted it to be approved as an OTC, and for the reasons I have described above, the FDA did not think OTC Primatene HFA was safe.
Finally, you bring alcohol and cigarettes into the equation. I would be perfectly happy if cigarettes were illegal. I also wouldn't strongly object if more safety procedures were put in place for buying alcohol. These are both entirely different products and issues. The issue isn't about other harmful things. The issue is not about the effect of CFC's on the environment- I am not even sure I agree with the decision to ban then in metered dose inhalers. The issue is whether or not rescue medications for asthma should be available for consumers over the counter-meaning without a prescription/without a physician's supervision. I don't think they should be. It is unlikely that we are going to ever agree on this.
Dr. Mintz, thank you for taking time out of your busy schedule to answer some of my concerns. It is unfortunate that the US spends more on health care than any other country but we don't have the best health care. In fact I think we rate somewhere around 20th in the world if I recall. No, I don't think narcotics should be OTC. That seems to be a red herring though as we know narcotics are very dangerous and addictive. You believe that Primatene should be by script only. That is your perogative. Unfortunately it is unavailable anywhere. Sadly, I hear silence from the medical community in bringing it back, even by script only. Like you I would be overjoyed if cigarettes etc were banned, but they are not and the medical community is not calling for them to be. But they want to prohibit asthmatics from something to help them. My PCP prescribed ProAir, for which I paid a $30 co-pay. Who knows how much they charge the poor souls without insurance? So I paid twice what a Primatene inhaler would cost and I estimate that the ProAir is about 20% as effective as Primatene. It also seems they jacked up the prices of albuterol related inhalers once Primatene was removed. MY PCP told me that albuterol was the ONLY rescue inhaler available. Supply and demand I guess, so up goes the price on an inferior product. So, again I ask, how exactly is the medical community trying to help us? As you know, an asthma attack or wheezing can start any time or anywhere. A doctor is always/usually not available (unless one wants to spends hundreds at an emergency room). We should have something available at a local drug store. Ironically, no mention has been made of the Primatene/BronkAid pills that are still OTC. While they help, they take 30 minutes to start working. Also, when the main ingredient, Ephedrine HCL, gets into one's system, a side effect is an "uppity" feeling. To me it would make sense to have that medicine go directly into the lungs instead of the body, yet that is available OTC where the inhalers are not. One quick thought: can we REALLY trust the FDA to have our best interests at heart? After they pulled Primatene and shot down an HFA version, I think not. Dr. Mintz, I think we will agree to disagree, but with all due respect, I believe if you had asthma you might see things a little differently. I know what I used to be able to do. Now with the inhaler and Intal no longer available I (and many others if one reads other asthma related sites) are suffering, often needlessly. Thank you for your time.
@anonymous 10/31. Thank you for your thoughtful response.
One point of clarification: The FDA did not exactly "pull Primatene and shot down an HFA version." All CFC inhalers were pulled from the market by a piece of environmental legislation not under control of the FDA. In other words, the FDA did not ask that CFC inhalers be discontinued, but rather oversee the newer formulations that are allowed under this new law. In addition, the FDA did not exactly "shoot down" Primatene HFA. Armstrong Pharmaceuticals, the makers of Primatene, submitted for Primatene HFA (years after losing the battle for an exemption) as an OTC only. The FDA committee actually voted in favor of the drug's efficacy (14 yes, 10 no, 1 no vote). However, when it came to safety as an OTC, they voted against it(7 yes, 17 no, 1 no vote). Armstrong could easily apply for Primatene HFA as a prescription drug and it would probably get approved. However, they made a business decision not to do this.
I completely understand how an OTC asthma inhaler would help patients who can't access a primary care physician for a prescription and/or can't afford their prescription medications. This would also be the case for blood pressure, cholesterol and diabetes medications. There are reasons why some medications are considered safe for over the counter use and some are not. While I really do hope we can fix our health care system so that everyone can have access to physicians when needed and affordable medication, I don't think moving certain medications to OTC status is a wise decision for the nation's health.
Well said, Annonymous! I think the real problem is the so-called experts in charge who really don't care about people that fall through the cracks. They have taken control of this situation for our own good. The pharmacist at Walgreens told me, you need to get to a doctor and get on Albuterol. I said, I have a doctor, that's why I am on Singulair, which helps but not for asthma attacks I mostly get at night. I said, I can't take Albuterol. It gives me asthma. She then said, well, you should try Advair (I am not kidding). I said Advair has Albuterol type medicine in it with a steroid, which I can't take anymore after years of being on steroids. Advair has the long-acting Beta2 adrenergic agonist. Albuterol has the short-acting. She said, oh ya, well, good luck. I wrote the FDA a bunch of letters and I got a reply that said, you need to go to the doctor and get on Albuterol. He said, epinephrine isn't a safe drug for asthma. Can't they hear or read? How safe is: not being able to breathe? The bottom line with this topic is: Primatene Mist has already been classified as safe for over-the-counter and that is why it was sold for so many years. So then the FDA stated that Primatene Mist wasn't pulled off the shelves for "not being safe". It was pulled off for its CFCs, according to the Montreal Protocol. OK, so even though Dr. Mintz said that it was Armstrong's fault for not changing their product to HFA, like Albuterol makers did, I noted that that isn't true, they did come up with their HFA version and the FDA still would not approve it because they decided it wasn't safe. So now they are trying to get it approved again but these so-called experts in charge keep saying, they will never accept it. And now, Dr. Mintz is still putting the blame on Armstrong for choosing not to get it approved for prescription only. Why would they? Albuterol products have monopolized the market already with doctors that ONLY recommend Albuterol and steriods for first line care and are charging twice as much for it as epinephrine. I have not seen ANY evidence that Albuterol products are safer than epinephrine. "Paradoxical reaction" is not a possible side effect of epinephrine according to my many drugs books, 2 are professional nurse's manuels, and anywhere on the internet. Not fair to us people that have asthma and can't use or afford Albuterol. Comparing Primatene Mist to blood pressure drugs doesn't make any sense. Taking blood pressue medication does not stop a heart attack. There are risks with every drug but people have a brain of their own for a reason. People that abuse any over-the-counter drug are the same people who will huff airplane glue or drink mouthwash to get high. Taking away these wonderful inventions to help us live and have a better quality of life, for people that can't afford it, is cruel and it reeks of survival of the richest. I am unique because I get a paradoxical reaction from Albuterol. I could die and not being able to breathe all night keeps me awake and will damage my heart, my life and my mental stability. Right now, at 63, I am very healthy but as soon as I can't get any form of epinephrine, my life WILL be ruined. The only people that show they care at all, after I have reached out all over the internet and to doctors, pharmacists and others for 4 years now, have been my family and people that have asthma. What a cold, uncaring medical community it looks like to me. They think, too bad, you are just a minority. They look at the bigger number for a variety of reasons. And Annonymous brought up an excellent example of double standard. You can get the Primatene Mist pills, even though they make you feel like you are sticking your finger in the light socket, no kiddding, for hours on end. NOT WORTH IT. That stuff WILL take you down unlike the rescue inhaler. So unfair!
Primatene Mist CFC was never really deemed safe for OTC by the FDA. Because it is such an old drug, the standards at the time were so loose, that the FDA at the time allowed it to be over the counter. The inhaler was pulled because of the CFC ban. The pill remains not because the FDA thinks the pill is necessarily safe, but rather that it is the FDA's policy not to pull something from OTC to prescription unless it shows that it is a severe danger. Mylan only tried to get Primatene HFA approved as an OTC. The FDA voted that it was effective, but not safe enough to be used as an OTC. As a new drug, the FDA applies the newer, more stringent criteria. Mylan could easily have asked for prescription status, and then patients like you would have an alternative for albuterol. Mylan chose not to do this. I have no problem with Primatene HFA being prescribed by a doctor and used by patients that can not tolerate albuterol.
Saphrona, you mention lack of access to medication because of the need to see a doctor and cost of medicine as a serious problem. I agree that this is a serious problem, and I truly hope we can get this fixed for all Americans. However, I don't feel that improper prescribing, i.e. Primatene OTC, is justifiable because the system is broken. We need to fix the system, but I can't support Primatene OTC just because the system is broken.
I appreciate that you are still following up with the comments on this Dr. Mintz. However, you and I have a fundamentally different view of the role of government. You say that improper prescribing is not justifiable because the system is broken. I agree with that. But that's not what we're talking about here. We're talking about RESTRICTING RIGHTS. No one is suggesting you should prescribe Primatene Mist. But you conflate prescriptions for something with access to something.
Dr. Mintz, thank you for your time but I am still not convinced. This is what I found: When the FDA approves something, like they did Primatene Mist, it has to be assured of the "safety" and effectiveness. My question is: if this drug is more dangerous than Aleve, then where is the proof? I can't find any. There are heart warnings when using Aleve.
In addition to stroke, heart disease, and gastrointestinal bleeding, other conditions also carry warnings related to naproxen use.
The side effects of Primatene Mist are mild according to the testing they have done for over 50 years. Where is the evidence that the FDA had proof that epinephrine wasn't safe for over-the-counter? I can't find any evidence of it. Please show me.
I am convinced that the FDA didn't have a right to deny the new HFA version "because" of the epinephrine safety issues. It was only the CFCs that disqualified Primatene Mist. And in the report I read, the FDA ruled against the new HFA Primatene Mist because of packaging instructions and the settling of the HFA contents in the canister.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm247196.htm
"Primatene Mist is approved by the Food and Drug Administration (FDA) for the temporary relief of occasional symptoms of mild asthma. FDA urges those who use Primatene Mist to see a health care professional now to switch to another asthma medicine. “There are many other safe and effective medications to treat the symptoms of asthma,” says Badrul Chowdhury, M.D., Ph.D., director of FDA’s Division of Pulmonary, Allergy, and Rheumatology Products. But you need to find out if you really have asthma".
This pulmonary-Allergy advisor voted to approve the new HFA drug: "I think the sponsor has shown for this particular limited indication that it would be adequate and safe," voting Pulmonary-Allergy Drugs Advisory Committee member Dennis R. Ownby, MD, professor of pediatrics, division of allergy, immunology, and rheumatology, Georgia Regents University, in Augusta, explained."
Tremor was the most frequently reported adverse event for E004 in Trials C and C2 combined, and all cases were mild.
Chest discomfort and chest pain were more frequent in the E004 group compared with placebo but were infrequent. There were no significant cardiovascular adverse events in terms of frequency, severity, or seriousness.
·
FDA approval: To acquire approval of a device through a PMA (premarket approval application) application, the PMA applicant must provide reasonable assurance of the device’s "safety" and "effectiveness".
So my question is: Is the FDA overstepping their bounds by deliberatly going against a product because of the strong opinions of doctors that don't understand the pharmacology of drugs and others that have a huge conflict of interest in wanting people to pay more at a doctor's office and pay way more for a different drug that many asthmatics complain about, saying something is wrong with it? Many of these doctors think you need to treat the disease, no matter how severe it is, with steroids. There is a growing number of doctors, like mine, who are saying, it is wrong to use steroids as the first line of defense against asthma. I was really angry when I realized that after I had to stop the steroids, after many years, my asthma got somewhat better and I became healthier overall. The first thing my doctor did, in 1968, was put me on steroids.
Isn't the FDA required to prove against, what they approved in the past, with new long-term studies?
@Saphrona Nelson- The FDA doesn't have to prove anything. It's the drug companies that have to prove their products are safe and effective in order to get approved. Just like Proventil, Ventolin, and Proair; Primatene HFA is a different drug than Primatene CFC (per FDA policy), so they had to re-submit an application for a new drug. Applications are reviewed by an advisory panel of mostly physicians. The FDA can decide whether or not to listen to their advice when making the final decision. Mylan submitted Primatene HFA for over the counter use only. The consensus from the panel was not that Primatene HFA was dangerous per se, but too dangerous to be approved as an OTC. Mylan did not ask for approval as a prescription drug, so Primatene HFA disappeared. I am not privy to why Mylan did not ask for approval for prescription Primatene HFA as well. However, I am guessing this was a business decision.
Finally, I can certainly understand why you believe physicians have a self interest in keeping all medicines prescription so a doctor's visit is required and therefore they make more money. This certainly makes logical sense, but is far from the truth. Most primary care physicians have too many patients. They see too many people in too short of time. This causes frustration for both the doctor and the patient. In addition, the amount that insurance companies pay primary care physicians for a brief asthma visit is less than many woman spend on a trip to the hairstylist. (Plus the overhead for physicians -staff, equipment, malpractice- is way higher than a salon.) As a certain candidate says "Believe me," primary care providers are not longing for more asthma patients in their office in order to line their pockets with cash. I believe the doctors on the panel, like myself, do care about patients and are concerned with improper use of rescue inhalers without consultation with a physician.
Dr. Mintz, thank you for your reply. I think I understand what is going on here now. Primatene Mist HFA is considered a new drug that has to go through all of the same scrutiny as any new drug. The new drugs are under higher scrutity than they were in the past. Many doctors and lung associations are against epinephrine because it is deemed less safe than Albuteral for a variety of reasons that I don't agree with. And it has even less support for being an over-the-counter asthma inhaler.
We depend on the drug companies to come up with different drugs to give people like me, who can't tolerate Albuterol, a choice. Otherwise people like me fall through the cracks. And people that can't afford insurance do too. I think the FDA needs to change this cruel control that Drug companies, just trying to make a profit in a capitalist society, have over drugs and other life saving devices. And no, I do not believe in socialism.
I am very upset about this and so are many others that have put their stories on the internet. Is there anything I can do to change this or to find something else that works like epinephrine? Asthmanefrin has been taken off the shelves now. It's really scary to think about what it's going to do to my life and others trying to breathe in an emergency..
Thank you, Dr. Mintz, for your time and effort.
@Saphrona your first paragraph is almost correct. It is not that doctors necessarily deem epinephrine more dangerous than albuterol (though some may). The issue was that epinephrine as an OTC rescue medication was unsafe. If any of the companies that make albuterol asked the FDA to approve their product as an OTC, they would probably say no for the same reason. Again, Mylan did not give the FDA a choice: approve as a prescription or approve as an OTC. They only asked to be approved by an OTC.
I truly recognize that there are certain people like yourself that don't respond to albuterol that respond better to epinephrine. I therefore would not have been opposed to prescription Primatene. As far as what should patients like yourself do now, I would strongly recommend speaking to your physician. I certainly can't give you specific medical advice over a blog, but there are other options including albuterol in a different device/formulation, nebulized medication and/or even getting medicines from outside the US.
Dr. Mintz: What about taking the Primatene Mist tablets, the main ingredient is Ephedra, and crush it up and mix with water and using that in a nebulizer? I wasn't able to tolerate Levalbuterol or using a nebulizer with Albuterol. I will ask my doctor also.
Thank you so much for your time and advice!
@Saphrona- I definitely would not crush up ephedra and mix with water. I would speak with your doctor. I know that epinephrine can be nebulized, but I don't think it comes in vials ready for nebulization, so you would need to work with your physician and/or pharmacist (mom and pop if you have one in your area, big boxes like CVS may not be able to do this) to get this right. The wrong mixture could be dangerous! Also, in addition to albuterol, there are other nebulizable long and short acting beta agonists.
Dr. Mintz, thank you again for replying. I guess my frustration is that Primatene came out somewhere in the late 60s/early 70s and has been available all these years until recently. The excuse, er, reason given was because of environmental reasons, not safety. Primatene HFA would have the same active ingredient, but now out of the blue they are screaming "safety!" Something just doesn't seem right. I live in Richmond VA, home to cigarette maker Phillip Morris. When I walk downtown I see a lot of people smoking. It burns me (no pun intended)that they can obtain this additive, obnoxious, and dangerous (to themselves and others) weed anytime in many stores. No mention of the environment or safety with tobacco! Yet if one has an asthma episode there is no inhaler available any place. This boggles my mind. I also question how substances are determined to be OTC. I haven't traveled much but from my little experience it seems the US has some of the most, if not the most, restrictive laws regarding when a drug can be sold OTC. For example, I used to buy Zyrtec from a Canadian pharmacy because it was OTC there but script only here. Sadly it cost less than buying it w/a script in the US, even with my insurance. Thankfully of course, that is OTC now, and much cheaper as a result. Thanks again for your time.
@anonymous, one thing you and I will both agree on is that smoking is horrible. I would have no problem with this being unavailable, or at least very difficult to obtain.
I don't write the policy, but the current FDA policy is that drugs that have been around for a long period of time (prescription or OTC) and were approved under less stringent criteria, stay on the shelves until they show they clearly cause harm. Primatene was approved over 50 years ago- before albuterol, before inhaled steroids, before many therapies that we have available today. It may or may not have been approved as a prescription today, but certainly not as on OTC. The concern is not so much the side effects, but rather improper use, i.e. treated asthma with just Primatene, when other medicines might be needed to prevent hospitalization and death. However, while it is likely that Primatene did lead to worse asthma outcomes, it didn't directly kill people, which is why it stayed on the market for so long. Don't be surprised if Tylenol gets taken away as an OTC. While it is generally safe, even when used as directed on the label, it has caused serious liver disease. (In Europe, Tylenol is the leading cause of liver disease that results in transplants). The FDA did not pull Primatene off the shelves because of safety, but rather because one of its ingredients was deemed harmful to the environment (by another agency). All other inhalers went through the process of creating new environmentally friendly products, but Mylan held out hoping for an exemption. When this failed, they eventually make their own environmentally safe version, but asked it to be OTC. Since this is a technically a new drug, the FDA applied the new safety criteria and said it was not safe as an OTC. We don't know whether the FDA would have approve Primatene as a prescription, because Mylan didn't ask.
Finally, if you live in Richmond, and have lung disease, I would highly recommend any of the pulmonologists at VCU.
Dr. Mintz: Thanks for the information! Thanks for caring!
Dr. Mintz, thank you for the explanation. I agree that using only Primatene for asthma is not wise and that it should be used in conjunction with preventive drugs/inhalers. However, I still think it should be available in some form. Of course, having inherited asthma, I am biased. :-) Also, thank you for your recommendation of doctors at VCU. Ironically, it was only a few years ago that VCU finally banned smoking outside their hospital, such was the tobacco influence here. One had to wade through clouds of smoke to get into the downtown hospital. Mercifully that is no longer the case. Unfortunately, Richmond was voted by the WebMD site a while back as the worst city in the US for asthmatics, so the battle continues. :-( Thanks again.
Saphrona, I hope you are doing well all things considered and I hope that your asthma symptoms will be reduced. God bless!
Anonymous,
Thank you! Same to you!! I have some new hope lately and Dr. Mintz gave me some information that I didn't think of. I still think Primatene Mist HFA needs to be approved by the FDA but I really don't think it will be.
Thanks for caring!!
Writing as someone who has endured asthma for my entire life, it's so very frustrating reading some of these posts. People who don't suffer from asthma constantly tell sufferers that Albuterol works just as well or "studies show...." - We actually have asthma and are telling you - NO IT DOESN'T!! UGGHHH!! Pick your head up out of the book or papers or wherever you are getting this information from and listen! Do you think all of the sufferers would be writing and searching 3-5 years after a medication has been banned for something that doesn't work!?!? If there was an equivalent alternative, why would we be so bent on Primatene? I've tried various alternatives and none of them work like Primatene. Now, if I have symptoms I am forced to go to the hospital. I honestly wished one of the alternatives worked. It's so frustrating and so sad - what if you couldn't breathe and someone took away the one thing that helped and told you to use an alternative that didn't? To add insult to injury, what if they told you "it did" work because maybe it worked for some other patient (that you've never met and has absolutely nothing to do with your situation). It's just truly disappointing and I'm sure there has to be something sinister behind this entire ban. I haven't come across a medication that didn't have side effects so it's definitely not that. For me, it's like a quality of life issue - When Primatene was an option, I knew I had an ailment but I knew that I could control it-now, if symptoms arise, I get anxious, my mind starts racing depending on where I am because I know if I have a full blown asthma attack I will have to go to the hospital (one time by ambulance), for them to shoot me with adrenaline to open up my airways to allow me to take a breath - it just bothers me because I know if I still had my Primatene, most likely, that would not be necessary.
Go Dee go! You are absolutely right. Unless one has asthma and has suffered with it they can't understand or sympathize with someone who does. I also know by experience that albuterol does not have anywhere near the effectiveness of Primatene. My health has certainly taken a hit by not having this medicine which once helped me so much. But hey, marijuana is now legal in several more states, with more states considering making it legal. Thus a recreational drug is OK, but a medicinal drug that is used to help for a necessity, is not. Only in America!
To all interested, here is an interesting paper (almost 3 years old now) by Armstrong Pharmaceuticals (makers of Primatene Mist) on the proposed reformulation. Very interesting reading, although it's filled with medical terminology. There is even a picture of the product's packaging near the end. Sadly, the FDA still turned their thumbs down.
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/NonprescriptionDrugsAdvisoryCommittee/UCM386676.pdf
Two comments about the document:
1. This is Amstrong's data and argument to the FDA advisory committee who make recommendations to the FDA. There are other similar documents from other scientists and invested parties that reach different conclusions.
2. Looking at this document (you can just go to the conclusion at the end) it is very clear that Amrstrong was seeking an OTC indication only for Primatene. There is no language that suggests they would prefer OTC but accept prescription status. The decision of the committee was not that it wasn't safe, but it wasn't safe as an OTC (similar to albuterol, which requires a prescription). If Armstrong really wanted Primatene available, they could have gotten approval for a prescription version. They never asked for this.
Thank you for your thoughts. I wonder how many of the "FDA advisory committee" were doctors, who could indirectly benefit financially by either banning Primatene or making it available by script only? In an earlier post you mentioned that the extra business is very little. But to me this would be a conflict of interest. Maybe the members of this committee were all decent and honest people. I wouldn't know. But it looks very suspicious. Where I work I couldn't accept even a free lunch from a potential vendor as thankfully my company stresses being above board in all business dealings. I also know from a couple of friends who worked in the medical field that it is different there. Drug reps often brought in free lunches for staff and provided various promotional "gifts" with the drugs name on it. One study showed that doctors who received these do prescribe that vendor's drug more often as a result. Doctors are certainly not immune to being influenced or doing things in self interest. Thus I question when the "committee" wanted to continue the ban on Primatene being OTC. "Safety" is frequently mentioned as the reason but not being able to breathe is also very unsafe. As an example,I recently developed a mild chest congestion, which as you know worsens asthma. On a good day albuterol will work OK. Not great but just OK. With the congestion I ended up taking 5 puffs in a short time with no improvement at all. Mercifully I still have some Asthmanefrin vials so I used one. With just 2 puffs it brought a HUGE (I sound like Trump!) improvement and I was fine the rest of the day. What is one to do if albuterol does nothing? If some docs had their way no other rescue inhaler should be available. How exactly is this safe? Or maybe they want us to pay for an office visit so we can get a shot of epinephrine (I assume doctor's office stock this??). We have been suffering for several years years now, often needlessly and due to the red tape of government/medical institutions. Frankly,from what I have read, I do not believe that the FDA is truly concerned with the health, safety, or well being of asthma suffers.
Hi Saphrona! I was at my local Wal-Mart and noticed that they had THREE boxes of AsthmaNefrin refills in stock! Previously they usually had none, or one at most. The expiration date was Feb. of 2018, which hopefully means they are making new product? Even though I don't need a box right now I grabbed one with my grubby paws because one never knows when the heartless FDA will swoop down and remove it, making our lives more miserable. As an aside, I had my script for Pulmicort refilled. Pulmicort is a steroid preventive inhaler which has been out for years. The price (WITH my insurance) went up to $60 from $30 the last time it was refilled, only 2 months ago. The "ProAir" (albuterol, also called "ChumpAir") inhaler was $30. Or twice as much as Primatene used to cost at a tenth of its effectiveness. I have noticed that asthma scripts have shot up especially with the new "HFA" inhalers. Their greed is taking huge advantage over the American people, especially sad since this concerns health. How they sleep at night is beyond me. I was cursing the medical establishment and FDA in particular under my breath as I left the pharmacy.
@anonymous
The medical establishment and the FDA do not set drug prices. The drug companies are the ones that set the prices, and under our current laws, there is nothing we can do about this. Both Trump and Clinton (it was the only thing I think they agreed on) thought this was a problem, so hopefully this will change in the future.
I have a tremendous amount of luck with my patients who have used GoodRx. In cases where the co-pays are very high, sometimes the GoodRx price (without insurance) is lower. In addition, almost all of the asthma inhalers have coupons that bring the price down. This works as long as you don't have Medicare or Medicaid. Simply go to the drug company's web site and download one. In many cases you pay $0 with the coupon.
Thank you, Dr. Mintz, for this valuable information!
@anonymous, thank you so much for this information! Dr. Mintz told me to check with my Doctor for Racepinephrine, (same ingredients in Ashmanefrin). So I did and he wanted me to try the Albuterol with a nebulizer first. He said some people have a bad reaction to the new HFA inhalers. So I tried it and it gave me asthma so bad and it took about 3 days for my lungs to recover. My lungs hurt and I coughed up congestion. The back of my throat was very swollen! So my doctor asked the pharmacy to track down Racepinephrine and they found it for me for $120 a month. I said, too expensive, I'll look on the black market. They said they could get this other stuff for $40 a month and I said OK, great. It was actually Asthmanefrin. I asked, why is it off the shelves and they said because stores don't want to get sued. So now you tell me Walmart has it. That's GREAT news! I live in Utah and they tell me they will never sell it here. At least I can get it and I can live my life without the hell of not being able to breathe. It's scary to think that our lives are in the hands of capitalists making money off the medication. I believe in capitalism but we need an overseer of those higher than the drug companies and those at the FDA, like Badrul Chowdhury, pulmunary director, who gives me no alternative. Kept telling me, get a doctor and get on Albuterol. Epinephrine is not safe. I wrote, I have a doctor. Albuterol gives me asthma. How safe is it to not be able to breathe?!! So now, I'm good. For now. I hope you are too!
My sister used Primatene for years and she ended up w small cell lung cancer. I believe Primatene had something to do w the cancer? I have searched the internet looking for any connection w with lung cancer, and came up empty. I'm sure the government doesn't want the public to know that it may, in fact caused lung cancer!
I don't believe that their is any reason to suspect that Primatene can cause lung cancer. Primatene's primary ingredient is epinephrine, which our bodies make naturally. Also, when Primatene was available over the counter, it was heavily used; so, if there was an association, we would probably know by now.
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