Yesterday, a US Food and Drug Administration advisory panel voted not to recommend Primatene HFA for over-the-counter sale. This is the latest in the attempt to bring a bronchodilator back to the over-the-counter market. There were two additional votes on the drug, and the mixed results could be reason for hope in seeing a new bronchodilator on the market in the future.
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Many of you may recall seeing Primatene Mist on drugstore and market shelves when you were younger. For me, it was a common occurrence as my cousin, who suffers from severe asthma, would often have this inhaler with him. After spending time in the backyard with my cousins and brothers playing football, he would pull out his inhaler, flip the top and use it if his asthma flared up.
_In 2011 Primatene Mist was phased out and removed from store shelves. These pocket-sized inhalers used chlorofluorocarbons (CFCs) to propel the epinephrine out and into the lungs of the asthma sufferer. As part of an overall move away from CFC-based propellants, the axe finally fell on Primatene Mist in December of that year. Since then, the manufacturer, Armstrong Pharmaceuticals, has been attempting to gain OTC status for a replacement inhaler, the short-acting beta2-agonist (SABA) bronchodilator, Primatene HFA. Currently, the only forms of this type of drug available are prescribed. If you have asthma, you might be familiar with their names, albuterol and levalbuterol. However, there is some need for an OTC alternative, particularly in case of emergencies or when people run out of their prescription at inopportune times.
_In addition to ultimately voting no to OTC use, the 25 member advisory panel also voted on the efficacy and safety of the new inhaler. While there is still another ongoing clinical trial, the panel discussed the results of two other clinical trials that showed significant results. On a vote over the efficacy, 14 yes votes won out.
_Lastly, the panel discussed and voted on the safety of the proposed drug. Like most drugs, Primatene HFA did show some side effects, though even with the most severe side effect being tremors, all cases were mild. Other side effects were infrequent. A larger safety issue was likely found in the correct use of the inhaler. While the new inhaler uses an ozone-friendly propellant, the new formula is a suspension that can settle. Consequently, the inhaler must be primed four times before the first use and twice after two weeks of nonuse. It must also be washed and dried each day, and both of these present significant hurdles when it comes to ease-of-use and proper use. With regard to labeling, some members felt that patients may be led to believe that it is for daily use when only actually intended for intermittent use. All of these things resulted in 17 panel members voting no, in terms of safety.
_The end result, for now, is that the new Primatene HFA will not be in pharmacy and store shelves any time soon, but the drug does show promise. It does work, and there is a need for it. Undoubtedly, Armstrong will revisit the inhaler and attempt to address issues of misuse or mishandling.
_Author: K. Gilmore
This is unbelievable! If anyone of you has suffered from Asthma, you would have voted differently. The new, so called approved otc that has been forced on us is a Joke. It doesn't work when I need it to, It is always clogging up even when I am following the cleaning instructions. And with no insurance, it is very expensive. Way to go voters.
This is insane. Primatene Mist is the only inhaler that brought complete relief to my daughter. It also lasts 5 times longer than any prescription inhaler. There is a huge need for something more portable/reliable than Asthmanefrin. Something is wrong here.
Absolutely agree! I have not taken a clean breath since it was taken off the market. You’ve got to love the politicians blasting pharmaceutical companies for profiteering all the while being the cause.
Disappointed that it wasn't approved and very disappointed that it was pulled from shelves without a replacement that was affordable. The new inhalers are script only, cost 60 to 80 without insurance and just don't work as well. To me it's all about the money, follow the trail and you'll see why it was pulled and hasn't been replaced.
It's particularly troublesome given the only other option that was/is on the market is Asthmanefrin, which is like a blend of the technology behind e-cigarettes atomizer and a traditional nebulizer/compressor.
Unfortunately, even this has presented problems, from complaints about choking to a variety of complaints from consumers about side effects. This prompted a voluntary recall by the manufacturer and warning letter from the FDA in the fall of 2013.
I would hope that Armstrong has enough of a vested interest and sees enough of a need to address issues with the delivery system and find a better and more user friendly solution”
Very disappointed that this was voted down. We all know the reason why and not sure anything will ever be done to reverse the decision!
the FDA does it again, they have no care for the average person, just politics, you can bet that the prescription drug manufacturers had a hand in all of this
I think that the old Primatine Mist with CFC's should be granted a waiver to the treaty so that the millions of suffers who depended on it can have effective, affordable relief from wheezing and shortness of breath. The use of this one product won't bring about the end of the world.
Of course this is politics. It's a disgrace. Congress is concerned about the CFC's in Primatine depleting the ozone layer. That is a joke people. What about all the brands of aerosol hair spray on store shelves? What about all the disinfectant sprays such as Lysol? Not one of these products has been taken off the market. Something is rotten in Denmark .
I miss my primitine. The inhalers I get by prescription do not seem to do as well as my primitine did. FDA panel please reconsider Ian so tired if my ribs hurting my headaches bring back the primitine….
This is all BS, Primatine worked for me for 50 years. Proair no.
Please bring back Primatine Mist! Please! I can't breathe.
Pretty amazing, that the new primatene inhaler would be considered difficult to use when Asthmanefrin, the Primatene alternative, is WAY more difficult AND expensive to use and always VERY inconvenient! Asthmanefrin works but it's not as reliable as Primatene used to be. If you drop the nebulizer, you are screwed if it breaks, needs new batteries every few days, needs a bath” every night, gets clogged and has to be replaced every 2-3 mos @ $60 a pop, so In my opinion this was a political decision @ the expense of asthma sufferers.”
do yall want money to retire with the benifits and know when you leave this world your kids and grandkids will still have money in social sercurity to retire and be able to take of your family then approve primatene hfa inhalers i have been in hospital at least 20 times since yall removed primatene cfc last visit cost over 77 thousand dollars which could have been prevented with primatene inhaler hfa less than 20 dollars if you dont care about your family being homeless,starving and sick because no real otc hfa rescue inhaler has caused social sercurity is broke because you didnt help us arent you going feel bad when you could have prevented it
Please reconsider. The alternatives are not as good and very expensive!!! I have tried everything but Primatatine is what I need. Tonight once again the alternative” inhaler didn't work and I am miserable!!!”
If primatene mist does not come up with a replacement soon there's high probability i will either die of an asthma attack somewhere or go entirely postal. My life is miserably without it. Its removal from the market was ridiculous to begin with i might add.
Just more Big Government intervention in life. Big Government knows what is best for you. Do as I day—-not as I do.
If I'm reading the right, the replacement Primatine would -not- be the same makeup as the original, which means even if it did pass it wouldn't necessarily be as effective as the original. Seems like a lot of waiting for something that won't necessarily be as good as the original. Just bring back the original until they can deliver the original formula with a new system.
I am starting to panic with the winter coming and my supply of primatene dwindling. I have tried others and nothing helps me to breathe when i have a cold like primatene. Asthma is so awful to have and it is so criminal to take something off the market that helped so many people to live with this disease. Please bring it back fast so we don't have to live in fear.
No prescription inhaler works nearly as good as Primatene Mist! To those who voted against the new version, try breathing through a straw an entire week and tell us what it feels like! Now we must visit and pay a physician so they can write an expensive prescription that does not work well. Incredible! If the environment was truly a concern, why aren't cigarettes banned???!! Surely they are worse for the environment. Oops, too much money to be made there too. I am getting more and more disgusted
As I'm suffering right now and these past few weeks and other times throughout the year, I hope the FDA is proud of itself taking this great product off the market. I wish it were just as simple going to the doctor to get an inhaler, but often it isn't sometimes.
Again, thanks for NOTHING!
I just wanted to jump in and say that I carried a Primatene inhaler for near 40 yrs. I can remember as a child when the Doctor handed me one and said use this, until the day that our wonderful government decided we were too stupid to have control of our own lives, this was the one thing that stopped the attack and gave immediate relief. Now it is gone, thanks again for Govt. over-reach, and this new crap is just that, CRAP. What it boiled down to was it worked, so some jackass decided that it needed to be controlled. I have suffered more for the last three years than I suffered in all the years previous… My doctor has tried numerous alternatives and they are in no way comparative and have to be used way too often.
I too have used Primatene Mist most of my life. Albuterol does not work as well and with having to go through my doctor, my drugstore, and my insurance company to be told how often and under what circumstances I am allowed to breathe is debilitating and ridiculous. It is clearly yet another move by the medical/pharmaceutical industry to mobilize profits.
It's important to remember a few things. While it's easy to blame the government, there are several moving parts to this. First, the medical community is somewhat split on the use of Primatene Mist. Most concede that when it was first introduced decades ago, it was extremely useful, but now, most physicians who have spoken on the issue also note the the current class of prescription drugs can work as or MORE effectively without the side effects. My father is an asthmatic, and has never been able to use Primatene Mist due to the side effects. He would get very shaky and his heart would race when he used it. These are two common side effects and are directly linked to the epinephrine used in Primatene and are often pointed out by physicians in making a case against use of Primatene Mist.
There is need for an over-the-counter bronchodilator, and even though most doctors would prefer that patients NOT rely on something like Primatene Mist in lieu of more effective treatments or better managed asthma, they're not so shortsighted to see the benefit that it has been for asthmatics over the last several decades. A quick trip around several physicians blogs as well as interviews with local physicians bears these conflicted views out.
The other part of this equation is the environmental one. The ban on CFCs is what originally triggered Primatene's path toward retirement. It's rather thin considering the amount of CFCs in the drug, but it's good to remember the context in which the ban came about. Remember the hole in the ozone? While the latest has shown that it has begun to get better, it has taken decades to see the positive effects from the ban.
All that being said, there should be room for middle ground. With health care costs being what they are and no true sense of universal coverage, increasing numbers of people have less and less money to spend on doctors visits or costly prescriptions. At the same time, a more effective rescue inhaler could be made available for OTC use. Perhaps a lower dosage per unit would be a way to make it more affordable. This solution, however, would likely need support from physicians groups and support from pharmaceutical companies to make what is right now a much more expensive prescription drug into a low cost OTC.
Like many issues, it's more complex and has more players involved than may appear at first glance.
Have you ever gone through an agonizing, terrifying, night of not being able to breath?
And knowing that there was once was a simple, inexpensive solution just arms-reach away and you are being denied it because, anyone in their right mind, would see it’s about pharmaceuticals and bureaucracy. It is not only deadly, on many levels, it’s dangerous and actually, probably has caused more deaths than “you” will ever know.
I’m tired of the rhetoric, just bring what everyone needs back, that obviously works and actually, I believe saves lives. I know it’s saved mine often, and now that it’s gone I suffer daily.
Like all medication, all medication OTC or prescription doesn't work for everyone. In the early '90's I tried some prescription allergy medication and had the same side effects as your father had with PM and now that medication is OTC. <br><br>Thankfully, in January I will have med insurance which is affordable and I can go to a doctor for a real prescription.however for millions who don't have access, Primarene is a real help, and because of its availability in the past, has saved me when I couldn't get to a doctor right away. <br><br>As for the CFC's, someone pointed out that cigarettes are much more harmful than a contained accelerant used only when necessary. Spray paint is still being made Not sure if they still use CFC's. <br><br>I'm very glad that there are still the PM tablets, which help some.
bribe taking scum in washington fda don't want inexpensive asthma relief. look at all the new asthma relief adds on tv for much more expensive meds to see what is really going on .
I wish these voters would get asthma and have no choice but to live with smokers and cats and all the things that make them unable to breath 24/7 like me! There is nothing that works against so many triggers except this and they don't seem to know this! Give me back my meds! They legalized POT in my state, but won't let me breath!? WTF
If they don't bring primatene mist back suicide may be on the rise among asthmatics. <br><br>Proair is horrible. When something actually comes out of the inhaler, it seems ok at first, but just ends up clogging my lungs making it harder to breath. <br><br>If the environment was a concern, why did they legalize pot in my state? Let MORE people smoke around me and take my only medication from the shelves? I have been taking primatene mist for over 30 years and can determine if it's good for me or not. proair doesn't last… it costs an arm and a leg.. it takes more time to go get when you can't breath you don't have time to make appointments and crap, and it doesn't work at all compared to primatene mist. Asthma is an emergency disease… LET US HAVE EMERGENCY ACCESS otc to our medication!
This is the emotionally-retarded and greedy medical estab in the US. Pushing on that junk inhaler as a replacement. Probably got a China cheap contract to make so they can charge us big dollars for it. This was a decision based on money not what's good for the customer.
Just suffered thru another attack with nothing better than Eucalyptus oil to inhale.
Primatene Worked for me. Side effects were tolerable, I just had to deal with them.
I have high $2500.deductible health insurance with no prescription coverage until deductible is met. I KNOW I AM Asthmatic! A $175 doctors visit to get prescribed a $200 per script Advair or Spiriva inhaler equals $375.
Primatene Mist was $30. OTC.
You cannot convince me this isn't about money and politics.
It was amazing to use. Just got to read the instructions and many people failed to do. So now they went and cried like bitches about how it was unsafe. Go back to booze you bozos! If you take that one hit it'll knock you down but that's where you have to relax before you go running around again. Drinking the soda seconds after using it will hurt so a good one hour after using it then take a drink from your fatteners.<br>The inhalers I was subscribed was ventolin and advair and they suck! So weak it's just stupid so I quit going to the doctor. I would rather die than take a medicine that sucks if I can't get my hands on Primatene Mist. Primatene Tablets suck too!Should of taken them down first over the mist. If taking several pills near heart attack is your only option then that's just lame.
Help. I cannot breathe. I used to use Primatene whenever an attack would flare up and it always worked. I have an elephant on my chest right now. This is not a chronic condition, thank God, but when it does strike, I'm miserable. Bring back that product to us sufferers!
The very first comment from kevvyg hit the nail on the head.
No one – and i repeat – NO ONE who suffers from asthma would have voted for taking Primatene Mist off the shelves in the first place, nor would they have voted against this proposed alternative.
I suffered from asthma for about 10 years growing up. There would be attacks so severe that i would be sitting on the couch frantically gasping for each breath as if i had just spent the last five minutes under water. There would be endless nights when i would lay awake wreathing in pain until dawn and praying for relief. No one who has experienced this can possibly understand what it's like.
One night after a bad bout my mom went to the store and came back with a small thin spray bottle of Primatene and my world immediately changed for the better. How can i explain what it was like having instant relief from asthma? I can't. Words diminish it.
I know this will sound grandiose and silly to those who have never gone through it, and for the sake of those who have i pray to god you never have a say in whether elixirs like Primatene should be banned.
After several years, mild asthma recently returned to me. Luckily I still had a Primatene Mist inhaler still on hand. It did wonders for me! I am chagrined that no replacement has been put on the market since it was removed years ago. Is this what is considered better health care that we supposedly have now????????
Primatene Mist was the best and prescription alternatives poor. I just went to the pharmacy to try to get my Ventolin albuterol refilled and was told that now THANK YOU SO MUCH MEDICARE ADVANTAGE BLUE CROSS BLUE SHIELDI had to pay full price. I lost Extra Help” from SSA, and I guess my medicare plan now doesn't cover ANY of my prescription costs. Well-I had $40 to my name and I needed food. So. . . no inhaler.
Why, in tHis day and age, hasn't Primatene or some other company come up with an OTC alternative? That thing that costs a fortune and dispenses a mist is useless. What can we do? Pharmacist says. . . well, you can go to the emergency room. RIGHT!!!! Does anyone out there have an answer?? a solution?”
I can’t find refills. Primatene Mist is gone, I’m tired of waiting.
Asthmanefrin gave me jitters.
I need something soon.
Has anybody used that Prime Asthma Relief?
Kellie
Unbelievable the incompetent worthless FDA takes this product off the counter. I hope they all get asthma real bad. This product is a life saver the speed at which it acts and the previous availability make it Superior to all the other products. The argument that the accelerant is bad for the environment is complete non sense. The amount in each bottle is insignificant compared to what the US used to use and what the rest of the world uses now.
Some body got paid off real good for this. I can only hope they get what is coming to them.
I am 68 years old and have had asthma all my life. I used Primatene for years and was able to lead a very active lifestyle, including running 1/2 marathons. Once Primatene went off the shelves, I had no choice but to seek a prescription.
With Primatene, I enjoyed good health and spent maybe $10 – $15/month on it. Now, my blood pressure is up over ten points, the pressure in my eyes has increased, and I guess I now have to worry about osteoporosis, when I never did before, all this at a monthly cost of over $200. Further, the active lifestyle I was once able to enjoy is no longer possible, as prescription asthma medication does not begin to approach the effectiveness of Primatene.
I would rather have a rapid heart beat once in awhile (I actually never did) and be able to lead a quality life at a reasonable cost than to not have a rapid heart beat, enjoy new health problems, and have it cost a small fortune.
This is money and politics, pure and simple. What do we have to do to bring Primatene back?!
When I woke up this morning, I seriously thought this may be my last day on Earth. I barely could get in a little air. After hitting Pro-air about 6 times, it became a little better. I missed work, again. I miss the Primatene Mist. Still cannot understand how it affects the ozone layer when we breathe it into our lungs, hold it until it filters thought out lungs and then breath back out. We all know what the real reason is, people like me spending hundreds of dollar at the doctors and pharmacies is what they want. I used Primatine since 1975 and had no problems with it.
17 people make decisions for millions of sufferers. Some freedom
Odd how something can be used for so many years
removed only because of the non-drug part
and now can’t be approved?
sounds oddly like a Drug company payola is stopping this from being OTC
looks like prime asthma relief is getting more traction since I asked about it here.
There is a hub page about it, and the testimonials are starting to convince me to try it.
A link to the youtube videos https://www.youtube.com/playlist?list=PLcX2eFdQe32yF0ILGLfBwA7y9OZ4ozUgO
it is a very sick world we live in the only thing that was effected with asthmas suffer was primatene mist and primatene tablet why some sick beaurcrat trying to make money with their product that don’t work and to make asthmas sufferous suffer it a sick world out their and all of them r going to hell for doing this