Saturday, April 5, 2014

Should We Bring Back Primatene Mist?

Imagine that you have been chosen to serve on a Food and Drug Administration (FDA) Advisory Panel that is being asked to review the application to approve a re-formulated Primatene Mist® for sale over-the-counter. Primatene Mist contains the bronchodilator, epinephrine. For decades it was available without a prescription, with many millions of inhalers sold. It was taken off the market at the end of 2011 because of the general ban on medications using the environmentally-harmful propellant, chlorofluorocarbons (CFCs). Primatene Mist has been redesigned now with the ozone-safe propellant, hyrdrofluoroalkanes (HFAs), and its manufacturer (Armstrong Pharmaceuticals) seeks to have it put back onto the shelves of pharmacies, markets, and convenience stores. How would you vote: “Yay” or “Nay”?

Let’s try to lay out the arguments, for and against approval. We recognize that there are many strongly held opinions on the topic, as a quick read of the “BringBackPrimateneMist” facebook page would suggest.

In favor of approval:
• Many people with asthma do not have a primary care provider to write for them prescription bronchodilators. They too need access to medication that can help their breathing, especially in an asthma crisis. This disparity of access to medication is especially pertinent to asthma, where the poor and minorities bear the greatest burden of the disease. Even some people with health insurance may find an over-the counter medication less expensive, and it can be purchased in a jam, when you discover that you have left your prescription bronchodilator at home.
• Epinephrine by metered-dose inhaler has been used by millions of people over more than 4 decades, suggesting its safety.
• Epinephrine is an effective bronchodilator that begins to work quickly (onset of effect within 1-2 minutes), though with a relatively short duration of effect (1-3 hours).

Against approval:
• Compared to newer (prescription) bronchodilator medications like albuterol (ProAir, Proventil, or Ventolin), epinephrine is more likely to cause heart racing and tremor.
• Selling a bronchodilator over-the-counter means that it can be obtained without medical guidance as to when, how often, and how much to use. Package labeling may carry this information, but more often than not it goes unread.
• An OTC medicine is available for purchase by children without medical or parental guidance.

Our take:
Primatene Mist sold over-the-counter perhaps made sense in an earlier era when our conception of asthma was a disease of bronchial muscle constriction. Take a bronchodilator medication that relaxes tightened bronchial muscles, open your narrowed airways, and all we be restored to normal. We now know better. Shortness of breath, cough, and wheezing are often due in large measure to allergic (or non-allergic) inflammation of the airways, with swelling of the airway walls and excess mucus production filling the bronchial tubes. Relying on a bronchial muscle relaxer to relieve symptoms leaves much of the cause of the problem untreated. By offering ready access to a medicine that treats only one aspect of asthmatic airway narrowing – temporarily – one invites insufficient treatment, delayed treatment, and the risk of more, not fewer, severe and dangerous asthmatic attacks. It is a step back in time for asthma treatment, not a well-reasoned advance forward. Why would one make an older, less effective bronchodilator available over-the-counter and restrict newer, safer, more effective bronchodilators to prescription only? Perhaps the way forward …in an attempt to make low-cost bronchodilators quickly available to persons who need them … is to make albuterol available over-the-counter in limited doses (for instance, in an inhaler with no more than 20 inhalations per device). The inhaler would provide enough doses to “buy time” while one seeks medical help, not so many that one relies solely on the bronchodilator medication and delays other crucial, potentially life-saving therapies. Of course, one could buy more than one such inhaler at a time, but the message would be clear: the bronchodilator inhaler is for short-term, quick-fix use only.

We recognize that this topic is controversial. Looking for allies to support our point of view, we have found the American Thoracic Society, the American College of Allergy, Asthma, and Immunology, and the American Association of Respiratory Care. We would note that the FDA Nonprescription Drugs Advisory Committee and the Pulmonary-Allergy Drugs Advisory Committee did meet to discuss Primatene Mist-HFA and voted in February against approval. The FDA has yet to make its final decision.


  1. very good article.

  2. I'm in FL and cannot get medical care. If it were not for OTC options, I would be dead.

    You may imagine a better treatment plan for me - which is a wonderful theoretical argument. But it's foolish to engage in such nonsense when you are living 'hand to mouth.'

    When I lived in MA, I had great medical care. (I went to BC and Simmons for my master's degree - then worked for many years). The few odd months when I had no care, I went to a place that offered reduced cost medical care after hours (the old boston evening medical clinic). But most of the time, I had great insurance.

    Where I am now, I have no options. None. I've tried. I simply don't qualify for anything.

    Perhaps you don't know what it's like to be as scared as I have been. Then you would know better, I'm sure. But you have no idea.

    I have a six month supply of Asthmanefrin right now. And, I have several - shall we say - donations.

    You have no idea what it's like when you have no choices. I have a child to raise. She would very much like it if I were to survive.

  3. I think this decision should be left up to the individual. Pulling this product from the market is/was a control freaks dream. In a free society, we would not be having this discussion. This product has helped many people in the past, and could in the future if big business wasn't spending great amounts of cash to influence the process.

    1. Too many prescription asthma inhalers have much greater side effects than what the FDAadvisory board found with Primatene HFA. The likes of Advair and Serovent come with black box warnings that can cause death from taking the medications and yet they continue to be sold. I used Primatene because it worked. Today I am taking Proair which is nothing more than a cheap subsituite with a counter. Really?

  4. I think the reason it was pulled was the usual strong arm of the control freaks. The so called CFC's were not enough to harm anything in the environment because the medication was being inhaled. I have asthma and was born with it, I relied on Primatene mist to control my asthma and breathing. Now you have to buy the OTC breather that works for about a week and then quits, regardless how often it's cleaned and cost 3 times as much of what Primatene cost. I have over $700.00 invested in these stupid breathers and as of this writing, none of them work. Bring back the Primatene Mist that works and what was affordable.

  5. Dear FDA, the law is killing me. It is draconian, to force people like me to live in a state of perpetual suffocation. I used Primatene Mist sometimes... rarely... as a rescue inhaler in my late 20's and early 30's. It worked great. I stayed active and was fairly healthy. Then you removed it from the shelf.
    Out of desperation, I went to the doctor and was prescribed a corticosteroid and ProAir/Proventil. The latter rescue inhalers are ineffective and constantly clogging up, and the Corticosteroid has led to a sizeable weight gain which I feel with every step I take. I can't breathe. So I feel like I must run for the rescue inhaler too many times a day. I read that QVar and medicines like it cause weight gain. That makes it that much harder to breathe. A vicious-cycle. I want out of it. I have had an 500% decline in health since the new policies against Primatene were enacted.

    Bring back Primatene Mist.

  6. It is sad to live in a nation that has chosen to bully it's own citizens, men women, and children --those who are living with a chronic lung disease. I have used Primatene Mist for over 40 years with no problems, and have not found a better or even comparable prescription medication. The side effects listed on the prescription medications are horrific. I would like to see a complete investigation done regarding the decision. I would think these people would have something better to do than create physical suffering for good people. Do they really believe that asthmatics are the cause of problems with the ozone? Really?? Something is terribly wrong!!

    1. I too have used Primatene mist for over 40 years and on a daily basis, one puff before going to sleep and occasionally after exercising. When it was taken off the market I had to start using the Pro-Air prescription. Figuring Primatene would return to the market a some time I was not too concerned about how substandard the Pro-Air results were. That was 3 years ago. My breathing issues worsened slowly over time until having to use the inhaler 4-5 time a day is not unusual. At that rate I began to wonder if at some point in the near future would I have to start taking one of the prescriptions such as Advair and risk all the side effect warnings they come with. One evening about two weeks ago I vaguely recalled putting a Primatene inhaler in my "emergency disaster kit" back in 2012. The first puff almost brought tears to my eyes. It was the first very deep breath I'd taken in a long,long time. Within three days of only using the Primatene I'm back to once at night and once after exercising. I know it's expiration date has long passed but it's working just fine and at least for a while, until it runs out, I can breathe again. Don't know what I'll do when that time comes. Just keeping my fingers crossed that the FDA will do the right thing and let us all breathe easier.

  7. Husband has had bad neck pain every since theyve change his inhailor never did this when he had primateen mist spray it help his head aches and his breathing almost lost him vouple times because dc couldnt get him in for a while, please bring back

  8. I say we choke every politician and fda dumbass that created this problem. Let them see what it feels like to struggle for a breath of air. Ohhh that's right, they can afford doctor visits and things like proventil cause they get government benefits, stupid useless pos government workers. FU

  9. I used Primatene Mist for over 30 years. Hey...I'm still here. Last night I had an asthma attack and found out that my method of delivering the over the counter Asthmanefrin was not working (a beauty mist gaget). If I could have my Primatene on my bed stand as I used to, I would have had one puff and been back to sleep. Instead I had to go to the emergency room.
    Then today I try to find a need a prescription for that...really? What for? Do I live in the United States? Why is government trying to control the very thing that has been keeping me breathing for 30+ years.
    Bring back my Primatene Mist!! NOW!!!

  10. Great post!!
    Thanks Christopher Fanta by sharing such an important details regarding Asthma through your blog. Every post provides awareness and knowledge to tackle this very disease.

  11. Isn't it interesting that everyone against bringing Primatene Mist back are those in the medical profession who stand to gain financially because one has no other recourse but to make - and pay for - an appointment with "god" so he/she can write a prescription for a product that doesn't work nearly as well?? What is the REAL reason Primatene was pulled? It obviously wasn't fluorocarbons because a replacement can be made. But that was voted down! So now we know the real reason. Hey medical community, why aren't you campaigning against cigarettes as a polluter and health menace? Why aren't you trying to keep them off the market? Oh yes, I'm sure they bring you healthy(no pun intended)profits from sicker patients. To those still opposed to bringing Primatene Mist back I have a test for you. Put a straw in your mouth for an entire day and breathe only through that. Oh yes, try to exercise too. I used to be able to jog 5 miles. Now under the so called "superior" inhalers I have trouble with a half mile. I know my body - you don't. I used Primatene for decades safely. There should be a convenient OTC option for people who either choose to use this product or can't afford the very high cost of health care at a medical office.

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  14. Jenny & Risperal attorney, thank you for your kind words. I find it ironic that one can go into a store and buy a case of cigarettes, which are very harmful to one's health, with the government's blessing. One can go to a liquor store and buy bottles of hard liquor with no problem. In some states - and soon probably the nation - one can buy pot. But to try and buy an inhaler which helps greatly with an essential of life - breathing - oops, they won't allow that! I know the AMA doesn't govern cigarettes or liquor, but I feel money must be the real motivator behind keeping Primatene off the shelves. I asked my PCP if there was any rescue inhaler other than albuterol available and he said no. While that is better than nothing, it is no where near as quick or effective as Primatene. A co-worker was out of work for months because she "OD'ed" on albuterol. She had a severe attack and kept spraying albuterol desperately seeking relief. They had to rush her to the ER. While no one can say, I wonder if she had Primatene Mist available if that could've been prevented or at least alleviated. Come on government, we are adults. Please give us our Primatene Mist back.

  15. Had a very bad night last night, not sure if I can take much more of this. Congratulations FDA you will have killed someone else because of your greed and stupidity. When you answer for your deeds, and you will, let's see if it was worth it!

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