FDA Reintroduces OTC Primatene Mist for Mild Asthma

Megan Brooks

Disclosures

November 09, 2018

The US Food and Drug Administration (FDA) has approved a new over-the-counter (OTC) version of Primatene Mist (epinephrine inhalation aerosol bronchodilator suspension) for the temporary relief of mild symptoms of intermittent physician-diagnosed asthma in patients aged 12 years and older.

Primatene Mist is the only OTC asthma inhaler available in the United States. It is manufactured by Amphastar Pharmaceuticals.

Some medical societies issued concerns about the decision. The American College of Allergy, Asthma and Immunology (ACAAI) warned about treating asthma as a "do-it-yourself disease," and the American Thoracic Society (ATS) expressed outright opposition to the FDA decision.

The original OTC Primatene Mist was taken off the market in 2011 because it contained chlorofluorocarbon (CFC) propellants. The new version contains hydrofluoroalkane propellants, which are allowed under current international and US law and are in prescription asthma inhalers.

The new Primatene Mist includes novel features, such as a built-in spray indicator and a metal canister, which replaces the glass container used in the original Primatene Mist, the company said in a news release.

The decision to put OTC Primatene Mist back on the market was not made lightly, FDA Commissioner Scott Gottlieb, MD, and Janet Woodcock, MD, director of the Center for Drug Evaluation and Research (CDER), said in a statement.

When Primatene Mist was pulled from the market during the CFC phase out, many people were not happy, including patients with mild asthma who had found relief using it. In addition, there was concern for underserved populations who had no other access to asthma treatment, the agency notes.

"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.

"We've taken measure of all of these considerations in discussing the benefits and risks of using an OTC product for the treatment of asthma and evaluating 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. We have heard from experts and gathered new information to inform our current view on these questions," said Gottlieb and Woodcock.

The agency said there is a "narrow population" of patients diagnosed with asthma who may benefit from having access to this type of OTC asthma inhaler. It is only appropriate for patients with mild, intermittent asthma. Patients with more severe asthma should undergo treatment from a healthcare provider to ensure an appropriate treatment plan for their condition, the FDA advises.

"For the right patient, our analysis of the data, including new information that was developed since this product was previously on the market, shows that there are no serious safety concerns when Primatene Mist is used as directed," the FDA states.

Theresa Michele, MD, director of CDER's Division of Nonprescription Drug Products, discusses the new OTC Primatene Mist and how differs from the discontinued version in a CDER conversation available online.

Not a Do-It-Yourself Disease

Upon approval, the ACAAI issued a statement warning patients not to stop taking prescription asthma medication in favor of Primatene Mist.

"Asthma is not a 'do-it-yourself' disease that you can treat yourself with OTC medications," said Bradley Chipps, MD, ACAAI president, allergist, and pediatric pulmonologist. "Anyone who has asthma should be working with an allergist to make sure they are on the appropriate medication to control their disease. People should understand they shouldn't go off their regular prescription medication to start taking Primatene Mist instead. That could prove very dangerous," said Chipps.

He added, "80% to 90% of people with asthma think their asthma is well-controlled when it's not. There are too many needless deaths, even in people with mild asthma."

The ATS had even stronger words about the approval, expressing flat-out opposition to the decision by the FDA to let the OTC medication back on the market. In a news release, the ATS states that the "FDA's decision will jeopardize patient safety."

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 recommend the use of inhaled epinephrine to treat asthma," the ATS states.

"Asthma is a serious respiratory condition, and even patients with mild or intermittent asthma can experience life-threatening asthma exacerbations. The FDA's decision implies that the 25 million Americans with asthma can self-medicate their asthma condition.

"The agency's decision will give patients the false impression that over-the-counter epinephrine can manage their conditions. Those who do treat their asthma with over-the-counter products will be denied access to more effective asthma medications that are proven to reduce asthma exacerbation, improve symptom control and have fewer side effects," the organization added.

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