FDA approves the return of OTC Primatene® Mist

Charlie Sieberg, Pharm.D., New Ulm Medical Center

Primatene® Mist (epinephrine) is an OTC inhaler removed from the market in 2011 due to the harmful environmental effects of chlorofluorocarbon (CFC) propellants. With a new hydrofluoroalkane (HFA) propellant, Primatene® Mist is again available OTC after its recent approval by the FDA for the temporary relief of mild symptoms of intermittent asthma in patients aged 12 years and older. This 160-spray metered-dose-inhaler administers 125 mcg epinephrine per spray and is currently available for $29.99 at Walgreens and CVS. For many patients, including low-income, elderly, or uninsured individuals who might have limited healthcare access, Primatene® Mist may provide much needed relief if used appropriately. The inhaler does need to be shaken and then sprayed into the air one time before each use, and should be cleaned every day after use to prevent medication buildup.

Although potential benefits exist, several respiratory medicine associations including the American College of Chest Physicians have raised concerns regarding the approval of this inhaler, pointing out that epinephrine is only symptomatic, not therapeutic, treatment for asthma and it is not a recommended treatment option under the National Institute of Health’s asthma guidelines. Frequent use of rescue inhalers has been associated with increased morbidity and mortality, and there is concern that patients attempting to self-manage their asthma symptoms with Primatene® Mist may delay in seeking necessary medical care, resulting in worse asthma outcomes. The FDA remains confident in the safety and efficacy of this OTC inhaler when used as directed for appropriate patients.


  1. Amphastar Pharmaceuticals. Primatene® Mist. https://www.primatene.com/. Accessed February 18, 2019.

  2. Sullivan MG. CHEST Physician, presented by MDedge. FDA approves Primatene® Mist return.
    https://www.mdedge.com/chestphysician/article/188986/asthma/fda-approves... Published November 15, 2018. Accessed February 18, 2019.