FDA Approves Return Of Non-Prescription Asthma Inhaler After 7 Years


Seven years after it was removed from the market, over-the-counter asthma inhaler Primatene has been approved by the Food and Drug Administration (FDA) again.

Does the agency have any concerns about the product this time?

Primatene’s Return

In 2011, popular OTC asthma inhaler Primatene was removed from the market because it had chlorofluorocarbon (CFC) propellants, a known ozone-depleting substance. Before then, it was popularly used for the temporary relief of mild, intermittent asthma symptoms, which is why many people objected to having it taken off the market. Such objections came in particular from patients who had been using Primatene successfully.

As such, and also in concern for patients who do not have other access to asthma medications, the FDA is reintroducing Primatene to the market. This time, the product instead uses law-approved hydrofluoroalkane propellants, which is the same type of propellants that prescription-only inhalers use.

Safe Use

Even before it was taken off the market, there were concerns regarding patient use of OTC inhalers to treat themselves for asthma, possibly foregoing treatment from health care providers. Taking such concerns, as well as the people’s need for the OTC medication, it was imperative for the FDA to make sure that patients understood the proper use of Primatene.

For instance, it must only be used for the temporary relief of mild, intermittent asthma, and those who are diagnosed with more severe asthma must not rely on it. Furthermore, even those diagnosed with mild asthma may have more severe bouts so it’s important to still work with a health care provider for an appropriate treatment plan especially since symptoms may vary from one person to another, and over time.

"We cannot stress enough the importance of seeing a health care provider for any chronic condition to receive a proper diagnosis and be put on a treatment plan that works for each individual patient," said FDA Commissioner Scott Gottleib, M.D., and director for the Center for Drug Evaluation and Research Janet Woodcock, M.D. in a statement. 

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