HomeWashington Letter2018 ▶ FDA Announces Approval of OTC Inhaled Epinephrine for Treatment of Asthma – ATS Registers Strong Concern
FDA Announces Approval of OTC Inhaled Epinephrine for Treatment of Asthma – ATS Registers Strong Concern

This week, the Food and Drug Administration announced its decision to approve inhaled epinephrine (Primatene Mist HFA) as an over-the-counter product to treat mild and intermittent asthma. 

The ATS is concerned and disappointed in the FDA’s decision to approve OTC epinephrine (Primatene Mist HFA) for consumer use to treat asthma.  The FDA’s decision contradicts existing and established clinical practice guidelines.  Several expert panels have produced evidence-based recommendations on the treatment of patients with asthma.  None of these guidelines recommends the use of inhaled epinephrine to treat asthma.  The National Asthma Education and Prevention Program (NAEPP), an expert panel convened by the National Institutes of Health, has issued treatment guidelines for the management of asthma.  NAEPP recommends against the use of epinephrine for treating asthma exacerbations, stating:

  • Drugs of choice for acute bronchospasm: Inhaled route has faster onset, fewer adverse effects, and is more effective than systemic routes.
  • The less beta2-selective agents (isoproterenol, metaproterenol, isoetharine, and epinephrine) are not recommended due to their potential for excessive cardiac stimulation, especially in high doses.” (emphasis added)

The ATS is further concerned that the FDA did not engage in a public discussion before reaching its decision.  In 2011, the agency removed Primatene Mist from the market because the product continued to use ozone depleting substances – CFCs – as a propellant.  In 2014, the makers of Primatene Mist sought FDA approval for a reformulated version of the product that used an HFA propellant.  At the time, the agency held a joint public meeting of the FDA OTC division and the FDA Pulmonary/Allergy drug division to solicit public input on the OTC application.  The ATS and several other patient and provider organizations expressed opposition to the reformulated product, noting that inhaled epinephrine was contra-indicated for the treatment of asthma. The FDA ultimately rejected the application based on a variety of considerations, including problems with the HFA version dose counter. 

It appears that the FDA reached its recent decision without any public input.  The agency did not hold a public meeting regarding the new drug application and there appears to have been no notice in the Federal Register requesting public comment. 

The ATS is 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. 

Last Reviewed: November 9, 2018