FDA approves Primatene Mist
Posted on November 12, 2018

The FDA approved Primatene Mist last week for over-the-counter (OTC) status. It was taken off the market in 2011 because of its CFC propellants, which have been shown to damage the ozone layer. It is now being reintroduced with an ozone-safe HFA propellant, the same one used in all prescription metered-dose inhalers for asthma and COPD.

Dr. Steven shares the concerns about this development that have been expressed by the President of the ACAAI, Dr. Bradley Chipps. Not only does the medication in Primatene Mist have more potential side effects than the asthma rescue medications available by prescription, but allergists should be involved in supervising the care of all asthmatics, whether it is an occasional evaluation for mild, exercise-induced asthma, or more frequent monitoring of people with more severe disease. Most important is that people with asthma need to have the asthmatic inflammation in their lungs monitored periodically to ensure that it remains well controlled.

Without receiving enough education about the inflammation in the lungs by seeing an allergist, patients often run the risk of controlling only their symptoms, and not the underlying asthmatic inflammation, with rescue medications alone. Rescue medications obviously play an important role in keeping people comfortable on a day-to-day basis, particularly with sports, but the important point is that the inflammation in asthma must also be controlled for the best long-term outcomes. The 10 people who die every day in the United States from their asthma succumb to the inflammation in their lungs that hasn’t been controlled, for one reason or another. That is why it is so critically important for people with asthma to partner with allergists to control their disease, not just use OTC rescue medications on their own. OTC medications often provide a more affordable option to prescription medications and are fine to use for that reason, but they do not substitute for the optimum control achievable by treating asthma in conjunction with an allergist.

The FDA has also released a statement on Primatene Mist, which can be viewed at fda.gov.

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