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Monday, April 19, 2010

FDA pulls CFC-propelled metered dose inhalers from production

In the late 1980s, a variety of legislation was passed to reduce the production and use of chlorofluorocarbons (CFCs) around the world. The concern is that CFCs are damaging to the Earth's ozone layer.

Beginning June 14, 2010, the FDA has mandated a phase-out of 7 metered dose inhalers (MDIs) that use chlorofluorocarbons (CFCs) as propellants. The products, which include Asmacort, Maxair, and Combivent, are prescribed for the treatment of asthma and COPD. Final phase-out will be December 2013.

The FDA has also posted a Consumer Health Information sheet to help clinicians and their patients prepare for the transition to other medications such as MDIs that use hydrofluoroalkanes as propellants.

The FDA news release explains the action as concordant with US obligations under the Montreal Protocol, which initiated the ban on CFCs in all marketed products, and the Clean Air Act. MDIs were excepted from these obligations, pending development of alternative delivery products.

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