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.
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
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.
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.
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.
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."
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. I will attempt to call the company on a weekday to get an update.
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