Manufacturer Pushes to Return Primatene Mist to Shelves


The only OTC asthma inhaler was pulled from the market at the end of 2011 due to environmental concerns, but its manufacturer is trying to bring it back.

The only OTC asthma inhaler was pulled from the market at the end of 2011 due to environmental concerns, but its manufacturer is trying to bring it back.

Amphastar Pharmaceuticals, the manufacturer of Primatene Mist, has launched a campaign to bring the OTC asthma inhaler back to the market. The inhaler was removed from pharmacy shelves at the end of 2011 due to its use of chlorofluorocarbon (CFC) propellants, which deplete the ozone layer.

The inhaler was removed from the market to comply with the Montreal Protocol on Substances that Deplete the Ozone Layer, an international treaty in which countries pledged to phase out specified substances that deplete the ozone layer by agreed-upon dates. The FDA initiated public discussion on the CFCs in epinephrine inhalers such as Primatene Mist in 2006 and, in November 2008, notified the public that these inhalers would be phased out at the end of 2011.

During these discussions, the FDA also announced the phase out of 7 metered-dose prescription inhalers that used CFCs. Five of these inhalers have already been taken off the market, and the remaining 2—albuterol and ipratropium, and pirbuterol—will be available until December 31, 2013.

Prior to its phase out, Primatene Mist was the only asthma inhaler sold OTC. It was indicated for temporary relief of occasional mild asthma symptoms. After the phase out, patients using Primatene Mist were advised to see a health care provider about switching their asthma medication. (Click here for our article with advice for former users.) Several prescription inhalers that had used CFCs were reformulated to use hydrofluoroalkane (HFA) as a propellant instead, but Primatene Mist was not.

Amphastar contends that an OTC inhaler is a necessity for many patients, particularly those without health insurance. Company representatives announced their campaign to bring Primatene Mist back on July 18, 2012, during a US House of Representatives Energy and Commerce Committee Energy and Power subcommittee hearing on the Asthma Inhalers Relief Act of 2012, which would allow the sale of the 1 million Primatene Mist inhalers the company says it has in storage until they expire in August 2013.

“We are fighting to get Primatene Mist back on the market, and donating all of the net profits to charity, because we believe in our product and want it to be abundantly clear we are doing this for the millions of Americans who used to rely on Primatene Mist and not to make money,” Jason Shandell, vice president and general counsel of Amphastar Pharmaceuticals, said in a press release. “We all strive to protect the environment, but we believe it is essential to have an over-the-counter inhaler available until a replacement without CFCs is available.”

The American Thoracic Society, however, has advised against bringing epinephrine inhalers such as Primatene Mist back to the market because epinephrine is no longer considered a safe medication for treating asthma. According to a statement made by the society’s president, Monica Kraft, MD, to the Energy and Power subcommittee, this view is shared by the American College of Asthma, Allergy and Immunology; the American Association of Respiratory Care; and the National Association for the Medical Direction of Respiratory Care.

In addition, Dr. Kraft noted, in 1999 the American Medical Association argued for stronger warning labels on OTC epinephrine inhalers to alert patients to the dangers they posed and encouraged the FDA to remove the inhalers from the market. According to Dr. Kraft, epinephrine dilates the heart and other organs when treating the lungs, causing increased heart rate. In older patients or patients with heart disease, this can lead to cardiac stress or heart attack.

“If the intent of the legislation is to restore a safe and effective asthma drug to the market place, then this legislative effort is misinformed,” Dr. Kraft said in her statement. “Inhaled epinephrine is not a safe drug for the treatment of asthma. The adverse side effects of epinephrine are serious and well documented. No current clinical practice guideline for the diagnosis and treatment of asthma recommends the use of epinephrine. In fact, asthma guidelines specifically recommend against inhaled epinephrine for treating asthma.”

The American Thoracic Society suggests that patients who have used OTC medications to treat asthma symptoms should see a health care provider and develop an asthma management plan that includes more effective and safer medications.

Previous Pharmacy Times coverage of Primatene Mist:

  • Recommendations for Patients Who Used Primatene Mist
  • Self-Care for Asthma & Allergy

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