September 22, 2007

FDA Proposes CFCs Phase-Out in Epinephrine Inhalers

WASHINGTON (Reuters) Sept 20 - U.S. health officials Thursday proposed phasing out the use of chlorofluorocarbons (CFCs) in metered-dose asthma inhalers that contain epinephrine.

The Food and Drug Administration said it had tentatively concluded that there were no substantial technical barriers to making epinephrine inhalers that did not release CFCs, which are used as propellants but deplete the Earth's ozone layer.

Under the FDA proposal, epinephrine metered-dose inhalers that contain CFCs would be removed from the market by the end of 2010. The agency said it would accept comments on the plan for 60 days and hold a public meeting.

Epinephrine metered-dose inhalers, which are sold over the counter, are used for temporary relief of occasional symptoms of mild asthma. If companies do not develop CFC-free versions, patients would need to obtain a prescription-only alternative treatment, the FDA said.

The United States has generally banned CFCs in consumer products such as hair spray since 1978, but their use has been permitted in medical products when the FDA deems it essential.



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