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When Will Primatene Mist Asthma Inhaler Be Available?

When I went to the grocery store in December of 2011, they were out of the asthma control medicine Primatene Mist, and did not know when they would get any more. I went to the drugstore, which had only a few packages left, and I bought one. There was a sticker on it that said that they would no longer be making Primatene Mist after December 31, 2011. I decided to do some research to find out what happened to Primatene Mist and why they were no longer going to be selling the product.

Primatene Mist was the #1 over the counter medicine to help treat bronchial asthma. It was very helpful in quickly treating asthma attacks. It is marketed by Armstrong Pharmaceutical Inc. It helped relieve shortness of breath, chest tightness and wheezing that was related to bronchial asthma, emphysema and other breathing problems that were diagnosed by a doctor. It widened the airway to make it easier to breathe.

Armstrong Pharmaceutical Inc, a subsidiary of Amphastar Pharmaceuticals, Inc,. is an American owned and operated company that is headquartered in Rancho Cucamonga in California. Their operating facilities are in California and Massachusetts.

Primatene Mist was taken off the market on December 21, 2011.

Primatene Mist was taken off the market on December 21, 2011.

What Happened to Primatene Mist?

Primatene Mist stopped being sold on December 31, 2011. Why are they no longer available on our store shelves? The FDA has banned all asthma inhalers which contain chloroflouorocarbons (CFCs). This ban only affects Primatene Mist because it is the only asthma inhaler that has been approved by the FDA to be sold without a prescription. CFC is used as a propellant to force the medication out of the container, creating the "Mist."

The United States signed an international agreement, called the Montreal Protocol on Substances that Deplete the Ozone Layer. It phases out chemicals that depletes the ozone layer, including CFCs. This layer of the atmosphere protects us from some of the sun’s harmful ultraviolet radiation, which can increase the risk of skin cancers and cataracts.

The ban for Primatene Mist is made to comply with this agreement.

There is an environmentally friendly alternative to CFC that can be used in inhalers. It is called hydrofluoroalkane (HFA). Primatene is working on switching their inhalers to HFA, but the new medication requires FDA approval.

Listed below is a history that explains Primatene Mist's progress and status in getting back on the counter.

In the meantime, people continue to need relief for their asthma attacks.

What to do for Asthma Relief

OTC

It is best to be prepared for an asthma attack. If you bought Primatene Mist before December 31, 2011, you can no longer use this product because its expiration date has been reached. The company is working on a new HFA asthma inhaler and getting it approved, but does not provide an estimated date for that occurrence.

Primatene tablets are available to treat bronchial asthma. Although they will not provide immediate relief, they can be used to help with your asthma. You should get them from your local drugstore to get them at a reasonable price, but if your local drugstore does not carry them, they are available on Amazon.

Dr. Mary Ann Block suggested magnesium in my interview with her.

Prescription

Until the new Primatene HFA inhaler is approved, you will need to get a prescription in order to get an asthma inhaler. If you want to avoid CFC, you can make sure you ask for an inhaler that is made with HFA. However, you will have to take some steps in order to use your asthma inhaler made with HFA.

  • Priming. If you haven't used your HFA inhaler in a while, you will need to spray one or two doses in the air to get the pump to give you an accurate dose of medication.
  • Inhaling. Make sure you use the proper technique for using the medication, since the spray does not come out as forcefully as it did with inhalers that contain CFC.
  • Cleaning. You will need to clean your HFA inhalers more often than you did your CFC inhalers.

I haven't used an inhaler with HFA, but these steps seem similar to the steps for CFC as well.


Primatene Mist is a Rescue Inhaler

My doctor has said that Albuterol is more effective than Primatene Mist anyway, and recommended that I take that instead of Primatene. Personally, both the products work for me.

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Primatene Mist is a rescue inhaler, and only works to treat the symptoms of asthma. Treating the symptoms alone allow repeated attacks, which can permanently damage the lungs. There are other products that help reduce or prevent the frequency attacks. There are also natural ways you can help prevent asthma attacks, such as working to reduce your triggers.

Be Prepared

If you have asthma, it is very important to be prepared for an asthma attack. Since Primatene Mist is no longer being sold, you will not be able to run to the drug store to buy an inhaler. If you are not prepared with enough stock of Primatene Mist, you will want to make an appointment with your doctor and get a prescription.

Is Primatene Mist Coming Back?

2012 Primatene Mist Updates

January 10, 2012: I called to customer service for the parent company. The representative told me that they do not have a definitive or estimated date that the product will be back on the store shelves. They are currently in the final stages of developing the CFC-free product, and are conducting clinical trials. Once they complete that, they will need to get FDA approval, which may take months or years.

February 8, 2012. The customer service representative told me that they do not expect to have an alternate product until next year. The company was required to take Primatene Mist completely off the market, so it will not be available anywhere else. They did not ship it outside the United States. I would think this means it is unlikely to be found in the Canadian sources mentioned in the comments, which I am now deleting. Ebay also does not have any listings for it.

March 25, 2012: I appreciate all of the insights you have been providing in the comments. I really feel for the people who have not been able to find solutions to their asthma problems. I am in the process of interviewing people in the medical community to find different options for asthma patients, and hopefully will come across something that will work for you.

June 13, 2012: Armstrong Pharmaceuticals announced a consumer warning about Primatene Mist inhalers that are already on the market. Some of the pressurized plastic coated glass containers are bursting. It provided some extra precautions.

  • throwing away the container if it has been dropped
  • don't store it in a car or in direct sunlight
  • don't keep it in tight areas such as pockets, since the valve stem or stress on the container neck can cause cracking or breaking.

On July 18, 2012, Amphastar Pharmaceuticals presented some testimony to the U.S. Congress, in the hopes that Congress will pass legislation to allow up to 1.5 million units that are stored in warehouses to be sold to consumers while the FDA approval is received. They stated that they did not know how to dispose of these units, and would give the profits to charity. Since then, two bills have been introduced in Congress.

There is also a petition to allow the use of these units to be sold. According to change.org, and Amphastar's own website, 1 million units are available, which have an expiration date of August 2013.

August 31, 2012: The customer service representative told me that they have created the new formula for Primatene Mist, and are currently working on finalizing the paperwork with the FDA. They are expecting the new formula to be available on the market at the end of 2013.

November 9, 2012: Commenter SuperWill has informed us that there is another over the counter medicine called Asthmanefrin that is being sold at CVS and Walmart. It uses the same main ingredient, epinephrine. Reviews of this product on Amazon indicates that it works, but is not as convenient as Primatene Mist.

December 1, 2012. Commenter Dingo44 has informed us that "The active ingredient in Asthmanefrin is 11.25 mg Racepinephrine, while Primatene Mist is .22 mg Epinephrine." and confirms that the Asthmanefrin is very cumbersome to use.

December 12, 2012, the House of Representatives voted down the bill that would have allowed Amphastar Pharmaceuticals Inc to sell its warehouse inventory of Primatene Mist. According to the Wall Street Journal, "The bill faced intense opposition from the American Lung Association, the American Thoracic Society and 11 other medical groups. They say that epinephrine, the active ingredient in Primatene Mist, can lead to racing heartbeats and heart attacks in some patients."

2013 Primatene Updates

July 25, 2013. Armstrong Pharmaceuticals, Inc announced that it has reformulated Primatene Mist with an environmentally friendly propellent called hydrofluoroalkane (HFA). It will continue to use the same active ingredient epinephrine. The company made a New Drug Application with the FDA for Epinephrine Inhalation Aerosol USP. The company is awaiting a decision by the FDA.

August 2013. The containers that the company was attempting to sell in June 2012, presumably the last to be produced have expired. My container expired in April.

2014 Primatene Mist Updates

February 25, 2014. A US Food and Drug Administration advisory panel voted not to recommend Primatene HFA for over-the-counter sale at this time. They did not believe that the risk / benefit ratio favored OTC sales. There is another clinical trial, so these results are not final. They were concerned that the dose indicator had a high failure rate, the device can clog easily if not washed daily, and the product allows for eight puffs a day, twice a week which is contrary to guidelines that suggest epinephrine is a poor choice for acute asthma therapy. The agency does not have to accept the suggestions of the advisory panel.

August 13, 2014. I called Primatene Mist's customer service number at 1-877-462-8363. The representative told me that they submitted their application to the FDA more than a year ago and are awaiting the approval. She said that they would announce any changes on their website.

2015 Primatene Mist Updates

January 27, 2015. I called Primatene Mist. The representative told me they are still awaiting approval from the FDA and do not have any additional news.

November 23, 2015 I am sorry to say that there are no new updates. I called the company and they told me that they continue to wait for approval from the FDA. They are cooperating with the FDA to provide whatever they ask for, and then have to wait some more.

2016 Primatene Mist Updates

August 2016. The website Primatene.com which had not been updated in a long time was discontinued, resulting in several broken links in this article. I have removed these links.

August 15, 2016. I called Primatene Mist's customer service. The representative told me that they are still waiting for approval from the FDA.

December 30, 2016 The FDA rejected the latest version of Primatene Mist inhaler, asking for a change in the label and packaging of the product. They also asked for another study to see if consumers could use the product correctly without the guidance of a healthcare professional.

December 30, 2016. Amphastar Pharmaceuticals issued a response to the FDA rejection. In it, Amphastar's CEO, Dr. Jack Zhang, stated: "While we are disappointed to have not received approval at this time, we intend to continue to work with the FDA during the post-action phase to address their concerns in the CRL by the middle of 2017 and bring Primatene® Mist back to the OTC market as soon as possible."

2017 Updates

November 27, 2017. The link to the FDA Consumer Update has been broken, which means they removed the page. A search on their site says that marketing has been discontinued.

2018 Updates

November 8, 2018. Great news! The Food and Drug Administration has now allowed Primatene Mist to be sold in stores without a prescription, after banning it for seven years. It is now made with hydrofluoroalkane propellants instead of chlorofluorocarbon (CFC) propellants which is known to deplete the ozone layer. Amphastar Pharmaceuticals says the inhaler will cost about $25 and should be on the shelves by the end of the year.

You should still follow the advice of a doctor, of course, especially if your asthma is severe.


I will continue to provide updates here. If you find out anything more before I do, I would appreciate it if you would let me know here in the comments.

© 2011 Shasta Matova

Comments: "What Happened to Primatene Mist Asthma Inhaler?"

Edge on April 04, 2019:

THANK GOD!!! It's about time. That Ventolin stuff is so weak now that you have to use 5-6 puffs just to feel relieved. One night after one of my night time asthma attacks (mine are allergy induced) I still did not have comfortable breathing and it followed the next morning. I bought one of the new Primatene for $30 and with one puff everything opened up and cleared up!!!

jlo on January 10, 2019:

It a fact that the Greedy Pharma powers that be, banned Primatine mist off the over the counter market for years to replace their 200.00 to 600.00 dollar a piece inhalers because they said primatine mist kills the ozone layers? right? wonder if anyone knows, that hair spray also kills the ozone layers. But they didn't ban hair spray..Why? ask Hillary Clinton and her Pharma associates. they should burn in Hell these bastards.should not have to pay through the nose to breath in the USA

Kit on January 04, 2019:

Found the new Primatine Mist in Walgreen's in Oregon today. I didn't think to price it. Didn't realize it was ever coming back, and I'm glad to see it available. Good luck, everyone.

Lenny on December 15, 2018:

I have been looking to buy the new version since approval in November and cannot find it anywhere. Has anyone here had success finding it?

Abdul Razzaque Nohri from Hyderabad, Pakistan on October 20, 2018:

Worth reading

Gerald E. K. on October 02, 2018:

Finally, a doctor figured out a way to provide us with a pure epinephrine asthma inhaler.. It just came out this year (2018). It's not cheap, at $75 for a 250 dose package but not all that bad. It's called EpiMist for Asthma OTC, 250 Inhalations - No CFCs, No Chemical Propellant, Just Epinephrine!, Sold by: Dr. Natural Healing. Got mine on Amazon.

BTW, after using Primatene Mist for 55 years, my doctor prescribed albuterol. I QUIT BREATHING. None of the MD's at the hospital could figure out what was happening. "Give him more albuterol". Damn near died.

Mark on May 25, 2018:

Primatene Mist saved my life 11,000 times. I am an authority on this product, because I have been using it for 34 years. It works twice as good as albuterol. I can remember getting upset when the price went from $9.99 to $13.00! My god, if you do not have insurance, albuterol costs $209.00 EACH! That is CRIMINAL! Honestly, hundreds of people have NO DOUBT died as a result contributed to NOT having Primatene Mist available. I do not need some arrogant power seeking doctor to administer this life saving miracle drug. SHAME ON THE GREEDY BASTARDS WHO HAVE BLOOD ON THEIR HANDS.

Stapleton on May 03, 2018:

Just ran out of my stockpile. Can't believe they are still dragging their feet on this.

Chuck Miller___ chumiller@yahoo.com on May 01, 2018:

My "Childhood" Asthma came Back and I started keeping a Primatene Mist around since 1964-- until EPA banned the CFC Propellant in 2011___ It was always a Saver and I used it ONLY when Needed--__ I called about the Changeover to a Differant Propellant and the Company said the Change to HFA was made within 6 months from Ban Date__-- We all know the "Money Thing" took Control __ and to H--L with ASTHMA Sufferers.--- ---__-- MAY-BE__President TRUMP can "Drown" this Part of the "SWAMP" ---___ EPA HEADS and FDA MONEY SCAMMERS.

joespeed on March 27, 2018:

Big Pharma is bullshit...I used Primatene for years with actual results..the CFC bullshit is all about money. I hope they all rot in an unbreathable hell for what they have done. FDA needs to approve the new Primatene and stop taking bribes!! I want to breath WITHOUT going broke !!!!!

Carol on February 05, 2018:

The comment about prescription albuterol and asking for HFA instead of CFC. ???? Thought CFC was banned in USA? Its all about the pharmaceutical companies controlling the market. The warnings on primatene mist is on prescription albuterol as well. Primatene works just as well and a lot cheaper. Take away OTC and you are forced to pay 3x the amount right into the pockets of the pharmaceutical companies.

Oliver on January 14, 2018:

Great job you do to keep us informed.

Bill Laughlin on January 05, 2018:

The FDA looked the other way in 1995 and approved Purdue Pharma's "time-released" Oxycodone, creating a huge groundswell of addicted opioid users, but they CAN'T work with Armstrong or Amphastar to approve a new version of Primatene Mist? All this is, is an excellent example of delay, delay, delay tactics and corruption inside the FDA (certainly NOTHING NEW). Meanwhile, mild asthma sufferers worldwide get shut out under the banner of "protecting the ozone layer"! What a joke.

Cindy Smith on December 24, 2017:

Thank you so very much for your perseverance on this. I really appreciate a good "bull dog" attitude when it comes to an important issue, and I tend to think our breathing falls into that category.

Chuck Miller--e-mail___chumiller@yahoo.com on November 06, 2017:

I used Primatene Mist since 1964-- Obviously , it was banned for others to earn Money-- It always worked for me and I did NOT worry__ Now I use Abuterol sulfate and I have to be Alert at all times pertaining to my Breathing_- Or _ I get caught "Off Guard" and of Course "NO EMERGANCY MEDICINE"" --__ I suppose Armstrong is Collecting from "Start-Ups" and NO ONE gives a Crap about People who CANNOT BREATH.

2nd Amendment on October 10, 2017:

If you dont already, use a spacer/holding chamber with your albuterol inhalers. a significant amount more medication gets deposited in the airways. The CFC crap on these inhalers is just what it is....CRAP. there is no way in heck that these inhalers did any damage to the ozone. what do the idiots think happens. They must think people go around and squirt inhalers in the air. Flipping idiots. The biggest issue with Primatene Mist wasnt the CFC issue but the fact that it was epinepherine. Stuff can kill you if use too much. Anyways get a spacer for your MDI's/Inhalers

FDA Insider on September 29, 2017:

As an FDA insider, I can say with confidence that Primatene Mist HFA will NEVER be approved. We thought that most of you would be dead by 2013 at the latest, but yet a few of you persist. No matter, this ban was meant to cull inner city minorities, many of who suffer from asthma and cannot afford several hundred dollars per doctors visit. The ban was an incredible success in that regard :-)

Derek C on September 29, 2017:

An OTC asthma inhaler that works is critical. The FDA doesn't like it because insurers and doctors don't get a cut. I haven't had asthma in 20 years, two nights ago I had a really bad attack. Of course, I'm not going to get a prescription in the middle of the night unless I want to pay a thousand bucks to go to the hospital (or more). So I had to suffer through it. This government BS needs to end.

janie on September 21, 2017:

Are there any new updates? ??? Really need primetine mist to be available again.

Jeremy on September 20, 2017:

The people who did this need to be taken out to the town square at high noon. How dare they. When did American's give up their freedom for tyranny? This is nothing but a money-making scheme between big pharma and big brother. They profit while people aren't able to breathe. The people who did this better hope there is not a god.

Bill chambers on September 05, 2017:

Really having a hard time without primatene its crazy! Have tried everything available!when will they realize that epinephrine is the only thing that works for millions of people. All we ask for is an inhaler with epinephrine. Albuterol causes throat thrush and doesn't work near as well

Jim on August 28, 2017:

I have been hospitalized 3x this year because I don't have primatine mist..I predict I will die this winter..doc gave me pro air doesn't help me..I used primatine mist for 40 years..I am 75..please get replacement ASAP..

Babs on August 14, 2017:

Sounds like big pharma do not want it to come back!