Primatene inhalers to be phased out this December: FDA

By Dr. Ananya Mandal, MDSep 26 2011

According to the Food and Drugs Administration (FDA), the Armstrong Pharmaceutical's Primatene mist inhaler will be discontinued on Dec. 31, and prescription inhalers are the only alternative to the over-the-counter asthma drug.

“All inhalers that might substitute require a prescription,” the FDA's Andrea Leonard-Segal, said at a news teleconference. “So those who use Primatene need to take action now to see a health care provider to get a replacement product.” Leonard-Segal is the director of the FDA's division of nonprescription clinical evaluation. “The clock is ticking on Primatene Mist, the only over-the-counter asthma inhaler,” FDA press officer Karen Riley said at the news conference.

“If you rely on an over-the-counter inhaler to relieve your asthma symptoms, it is important that you contact a health care professional to talk about switching to a different medicine to treat your asthma,” said Dr. Badrul Chowdhury, director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA's Center for Drug Evaluation and Research.

Primatene contains chlorofluorocarbons or CFCs, which deplete the Earth's ozone layer. Environmental treaties signed by the U.S. banned products that emit CFCs. Most of these products already are gone. But medicines got a special extension. That extension has expired for Primatene. Sales must end at the end of the year. Although the manufacturer of Primatene promises to come up with a version propelled by a safer chemical, the company has not yet done so.

This means that users of Primatene, which has epinephrine as its active ingredient, must switch to drugs based on albuterol. And a prescription is needed for albuterol-based inhalers. These include Accuneb, ProAir, Proventil, Ventolin, and Vospire. While albuterol is a safe and effective asthma drug, it is different from epinephrine.

“I think patients will feel a difference,” Leonard-Segal said. “One person may feel a certain drug works better for them, but all FDA-approved drugs work in the populations for which they are approved,” Sally Seymour, MD, deputy director for safety in the FDA's division of pulmonary, allergy, and rheumatology products, said at the news conference.

Another difference users may feel is the price. A replacement cartridge of Primatene Mist sells for about $18. The albuterol inhalers sell for about $45 and up. However, patients with health insurance that covers prescriptions, and those covered by Medicare and Medicaid, may actually pay less for the drugs.

FDA estimates that 2 million Americans purchase 4 million Primatene units each year. Two other prescription inhalers - Boehringer Ingelheim's Combivent Inhalation Aerosol and Graceway Pharmaceuticals' Maxair Autohaler -- are scheduled to be phased out by the end of 2013.