Popular OTC asthma inhaler is back amid concerns

Consumer and physician groups expressed “deep concern” over FDA allowing an asthma medication to be sold again after it was removed from the market 7 years ago.

Over-the-counter Primatene Mist (Amphastar Pharmaceuticals) was removed from the market in 2011 because its formulation at the time contained chlorofluorocarbon (CFC) propellants, which are known to deplete the ozone layer, said FDA Commissioner Scott Gottlieb, MD, and Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, in a statement.

However, the new version of Primatene Mist-which provides temporary relief for symptoms of mild, intermittent asthma-contains hydrofluoroalkane propellants, which are permitted under current international and US law, FDA said.

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Still, FDA’s approval of OTC Primatene Mist “endangers people with asthma by suggesting asthma is a ‘do-it-yourself’ disease treatable with OTC medications,’” said Allergy & Asthma Network, American Association for Respiratory Care, American College of Allergy, Asthma & Immunology (ACAAI),American College of Chest Physicians (CHEST),American Lung Association, American Thoracic Society, and Association of Asthma Educators in a statement.

"Anyone who has asthma should be working with an allergist to make sure they are on the appropriate medication to control the disease," said allergist Bradley Chipps, MD, president of ACAAI, in the statement. "We want people with asthma to understand they should not go off their regular prescription medication to start taking Primatene Mist. That could prove very dangerous.”

The organizations noted that Primatene Mist does not treat asthma; instead, “it masks the symptoms that come from asthma.” “Furthermore, Primatene Mist's active ingredient is racemic epinephrine, which is not a recommended asthma treatment under the National Institutes of Health's "Guidelines for the Diagnosis and Management of Asthma,” the groups said.

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However, Gottlieb and Woodcock noted that the OTC drug is approved only for those who have been diagnosed with asthma by a healthcare provider and that asthmatics should be under the care of a healthcare professional. “Asthma is a serious health condition that requires careful assessment and ongoing follow-up with a health care professional. It’s important for us to note that Primatene Mist is not a replacement for prescription asthma treatments,” Gottlieb and Woodcock said.

When Primatene Mist came off the market during the CFC phase out, many people objected to the removal of the product, Gottlieb and Woodcock added. “Among those were patients with mild asthma who had been using the product successfully. There was also concern for underserved populations who had no other access to asthma treatment,” they said.

“At the same time, we also heard from practitioners concerned with the product remaining on the market. They believed asthma patients could be harmed by self-medicating with an OTC product and that appropriate asthma care included regular care and supervised care by a health care provider, including the use of inhaled corticosteroids or other controller medications to reduce inflammation and the incidence of exacerbations,” Gottlieb and Woodcock said.

As a result, FDA considered all the benefits and risks of using an OTC product for the treatment of asthma and “evaluated whether use of an OTC product could potentially forestall treatment for people who needed long-term care for chronic asthma from a health care provider,” Gottlieb and Woodcock said. “We have heard from experts and gathered new information to inform our current view on these questions.”

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