Dow Jones Newswire reports that the US Food and Drug Administration says that Primatene Mist epinephrine inhalers, which are the only over-the-counter inhalers approved by the FDA, will not be produced or sold after December 31, because they use chlorofluorocarbons as propellant.
The AP reports, “The FDA finalized plans to phase out the products in 2008 and currently only Armstrong Pharmaceutical’s Primatene mist is still available in the US.”
The CNN “Chart” blog reports that “asthma patients can continue using an inhaler that’s not empty by the December 31 deadline as long as the expiration date is still good.” While many asthma inhaler “manufacturers have already replaced their CFC inhalers with a propellant called hydrofluoroalkane or HFA, which is more environment-friendly…there’s currently no HFA version of an epinephrine inhaler available.”
The NPR “Shots” blog reports that “environmental groups have been working since 1987 to phase” CFCs “out under the Montreal Protocol on Substances that Deplete the Ozone Layer. The epinephrine inhalers are one of the last consumer products with CFCs to disappear from the market.”
MedPage Today reports, “Two CFC-propelled products — one combining ipratropium and albuterol (Combivent Inhalation Aerosol) and another containing pirbuterol (Maxair Autohaler) — may stay on the market until Dec. 31, 2013, according to the FDA. However, the transition has been controversial, as CFC-driven inhalers that were available in relatively cheap generic forms have been replaced with branded products at more than double the cost.” The FDA’s Andrea Leonard-Segal, MD, suggested that “companies selling the prescription products have programs to defray some of the out-of-pocket costs for qualified patients,” and that “there may also be assistance available under Medicare and Medicaid.”
From the American Association for Justice news release.