Primatene inhalers to be phased out this December: FDA

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.

Dr. Ananya Mandal

Written by

Dr. Ananya Mandal

Dr. Ananya Mandal is a doctor by profession, lecturer by vocation and a medical writer by passion. She specialized in Clinical Pharmacology after her bachelor's (MBBS). For her, health communication is not just writing complicated reviews for professionals but making medical knowledge understandable and available to the general public as well.


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  1. Zucker Zucker United States says:

    The people who are doing this to the nation's asthma sufferers should be FORCED to experience what it is like to not be able to breathe several times a day!!!  

    Maybe THEN, they'd have a little heart, and not try to kill those of us - who have this breathing problem with their unmitigated stupidity.

    Will they be held liable for the impending deaths that will certainly occur from this action?

    Will they pretend it's the Asthmatic's FAULT for not getting a medically-approved inhaler?

    Well you stupid jackasses, we have a RECESSION with 17% or more people unemployed. Only 10% are still seeking a job, and that's what they measure.

    Without an income, how can you see a Doctor? or PAY TWICE AS MUCH for a less effective medicine.

    Yes. This sucks. And it's just the beginning of Obama'sCare.  SCarey isn't it?

  2. Becky Becky United States says:

    This has to be the most single handed stupidest decision our government has made,  Please explain how it is dpleating our ozone, when we actually breathe in what clmes out.  We do not randomly walk around spraying the stuff.  Besides the fact that if we could afford to see a DR. for our illness we most likely would have done that instead of treating ourselves over the counter.  These types of decissions are maki.g me question my pride for my  country.

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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