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FDA To Phase Out Some Primatene Asthma Inhalers

September 23, 2011

 

An over-the-counter asthma inhaler is to be banned beginning next year because federal health officials said it produces carbon gas that is harmful to the environment, Reuters reports.

The inhaler in question is currently the only over-the-counter inhaler on the market, which when banned, will leave asthma patients with only prescription-based choices.

The Food and Drug Administration said on Thursday that chlorofluorocarbons (CFCs) in the metered-dose inhalers that contain epinephrine will be taken off the market after an international agreement was struck to ban all CFC products because they deplete the Earth´s ozone.

The inhaler, called Primatene Mist, marketed by Armstrong Pharmaceuticals, is used to temporarily relieve occasional symptoms of mild asthma, and has been the only FDA-approved over-the-counter inhaler available without a prescription, the FDA said in a statement.

The FDA first proposed phasing out CFCs in asthma inhalers in 2006, and finalized the phase-out in 2008. Most inhaler manufacturers have switched to using hydrofluoroalkane as a propellant. These inhalers treat the same asthma symptoms but are only available with a prescription.

Primatene Mist inhalers are now labeled with a notice saying they cannot be used after December 31, 2011. The prescription alternative will be more costly, but also more eco-friendly.

One million to 2 million patients in the US still use Primatene Mist. The FDA said that it is difficult to get an accurate estimate of how many people use over-the-counter drugs.

Asthma is the most common chronic disease in children in the world. In all, more than 235 million people suffer from asthma worldwide, according to the World Health Organization.

Two prescription-based inhalers — Boehringer Ingelheim´s Combivent Inhalation Aerosol and Graceway Pharmaceuticals Maxair Autohaler — that use CFCs will be phased out by the end of 2013.

The US began phasing out CFCs used in consumer products back in 1978, but the FDA allowed most medical products to continue to use them.

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Source: RedOrbit Staff & Wire Reports



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