ATS Opposes FDA Approval of Over-the-Counter Epinephrine

The American Thoracic Society (ATS) says it opposes the US Food and Drug Administration’s (FDA’s) recent approval of the over-the-counter epinephrine (Primatene Mist HFA) for consumer use to treat asthma.

“It is with our extensive clinical expertise in the treatment of asthma and our concern for the patients that we oppose the FDA’s decision,” said the ATS.

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According to the ATS, the FDA’s epinephrine approval contradicts existing and established clinical practice guidelines that have been set by groups, such as the National Asthma Education and Prevention Program (NAEPP). And in none of those guidelines is inhaled epinephrine suggested as a treatment for asthma, the ATS writes.

In fact, the NAEPP recommends against the use of less ß2-selective agents, including epinephrine, for treating asthma exacerbations because they can potentially cause excessive cardiac stimulation.

By approving an over-the-counter treatment, the ATS is concerned that patients will think epinephrine alone can manage their conditions, missing out on more effective asthma medications.

In addition to jeopardizing patient safety, the ATS believes the decision also undermines trust in a public policy process.

The group notes that the FDA did not hold a public process in reaching its recent decision. This is different from when, in 2014, the FDA gathered input from the public when considering an application for over-the-counter epinephrine. Then, the public expressed its concerns, and the FDA cited those when it decided to not approve the application.

“We are deeply disappointed that the FDA chose to make a policy decision that potentially affects 25 million Americans with asthma, without seeking their input or that of their providers,” the ATS wrote. “As physicians who care for patients with serious respiratory diseases—like asthma—we strongly urge the FDA to reconsider its decision.”

—Colleen Murphy

Reference:

ATS opposes FDA decision to approve over-the-counter epinephrine for the treatment of asthma [press release]. New York, NY: American Thoracic Society; November 12, 2018. http://www.thoracic.org/about/newsroom/press-releases/journal/ats-opposes-fda-decision-to-approve-over-the-counter-epinephrine-for-the-treatment-of-asthma.php. Accessed November 14, 2018.