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FDA Panel Calls for Ban on Some Asthma Inhalers

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TUESDAY, Jan. 24 (HealthDay News) -- Some over-the-counter asthma inhalers should be removed from the market because they contain a propellant that can harm the ozone layer, a U.S. Food and Drug Administration advisory panel recommended Tuesday.

The Pulmonary-Allergy Drugs Advisory Committee voted 11 to 7 to recommend that the FDA ban Primatene Mist and other nonprescription inhalers. The agency usually follows the advice of its outside panels of experts, although a decision can take months, the Associated Press reported.

Wyeth Consumer Healthcare, the maker of Primatene Mist, estimates that 3 million Americans use the product for mild or intermittent cases of asthma. Two-thirds of these people also use a prescription inhaler and rely on Primatene as a backup. In addition, 700,000 people use it because they don't have a prescription for an inhaler or lack health insurance, a Wyeth spokesman told the AP.

The over-the-counter inhalers that the panel recommended banning contain epinephrine plus chlorofluorocarbon, or CFC, which propels the medicine into the lungs of patients.

CFC has been used as aerosol propellants in many products but is being phased out because of harm it can cause to the Earth's protective ozone layer. Wyeth has asked that the FDA delay any ban on Primatene until it is ready to sell an approved CFC-free version, sometime before 2010, the AP reported.

One expert thinks over-the-counter asthma inhalers should not be sold for medical reasons.

"I don't think you would find any doctor that was in favor of having over-the-counter inhalers like Primatene Mist available to patients for medical reasons, not just environmental reasons," said Dr. Len Horovitz, a pulmonary specialist at Lenox Hill Hospital, in New York City.

With these inhalers available over-the-counter, some patients tend to diagnose and treat themselves, Horovitz said. "They will over-treat themselves and suffer from the side effects," he said. "And they will not have control of their underlying asthma."

Primatene Mist is basically epinephrine, which can pose cardiac side effects, Horovitz said.

"Anybody who thinks they have asthma should consult a physician and get on a daily maintenance regimen so they have no need for a rescue inhaler like Primatene," he said. "Using a rescue inhaler means that the asthma is not under control," he added.

More information

The National Heart, Lung, and Blood Institute can tell you more about controlling asthma.

SOURCES: Len Horovitz, M.D., pulmonary specialist, Lenox Hill Hospital, New York City; Jan. 24, 2006, Associated Press
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