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Non-Prescription Asthma Inhalers May Be Banned

January 28, 2006

Advisers to the US Food and Drug Administration (FDA) have recommended that the FDA agency ban over-the-counter asthma inhalers because they contain chlorofluorocarbon propellants that endanger the ozone layer.

Members of the Pulmonary-Allergy Drugs Advisory Committee voted 11-7 that the asthma inhalers, which include the popular Primatene Mist, present a threat to public health.

This type of asthma inhaler contains chlorofluorocarbons (CFCs) that act as propellants, shooting epinephrine into people's lungs. However, despite their negative effects on the ozone layer, CFCs are deemed safe for human use.

Wyeth Consumer Healthcare, who manufacture Primatene Mist, said they were "disappointed in the committee's decision," according to MedPage Today, as the inhalers do not pose a direct health risk to users.

The company estimates that about three million Americans use Primatene Mist to treat their mild asthma. In 2005, Primatene Mist generated about $43 million in sales, according to Wyeth.

Wyeth is trying to develop a CFC-free inhaler that it hopes to market by 2010. This inhaler will instead use hydrofluoroalkanes as a propellant, but the device will require clinical testing before it receives approval for sale.

Chlorofluorocarbons and Cancer

Chloroflurocarbons are non-flammable chemicals that contain carbon, chlorine and fluorine. For decades, CFCs have been used in aerosol sprays, foams and packing materials, as well as many other products, according to the National Oceanic and Atmospheric Administration.

Since CFCs were first introduced for commercial use, scientists have discovered they post a significant threat to the environment, eating away at the earth's protective ozone-layer. For this reason, CFCs are being phased out of use in all commercial areas.

The Environmental Protection Agency (EPA) believes that reducing CFC discharge into the atmosphere will help to maintain the ozone layer and thereby reduce the rate of skin cancers and cataracts caused by exposure to ultraviolet light. The EPA expects that this phase-out will results in 295 million fewer cases of non-melanoma skin cancers in the next century, citing data that data suggest a 1% decrease in ozone may increase non-melanoma skin cancers by 2%, according to MedPage Today.

Concerns Over Inhaler Use

According to some doctors, over-the-counter inhalers such as Primatene Mist may pose other health risks. Although they offer a less expensive option for people with asthma who lack insurance, some physicians have concerns that asthma patients will use them to self-medicate, without seeking appropriate medical advice for their asthma symptoms.

Many doctors prescribe albuterol inhalers, such as Ventolin, for asthma.

"Given a choice, I would like to have this particular inhaler not on the market because of the concern that some patients may misuse it," said Pramod Kelkar, MD, of Minneapolis, a member of the American Academy of Allergy, Asthma, and Immunology, according to MedPage Today.

"It's better that patients get the right diagnosis and the right treatment, and that particular path is harder when such inhalers are available over-the counter."

Source: FDA Panel Calls for Banning OTC Asthma Inhalers, MedPage Today, January 25, 2006.

Posted: January 2006

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