FDA Panel Mulls Safety of Asthma Meds
Dec. 11 -- THURSDAY, Dec. 11 (HealthDay News) -- The safety of four asthma medications will be weighed by a U.S. Food and Drug Administration expert panel as two days of hearings end Thursday.
The controversy over these drugs has been going on for several years, with two FDA officials recently calling for banning the use of these drugs for anyone under 17.
One expert thinks the problem is not with the drugs, but with their misuse.
"This is an over-interpretation of the risk without adequate consideration of benefit," said Dr. Miles Weinberger, a professor of pediatrics at the University of Iowa. "However, there has been irresponsible marketing of the products, salmeterol and formoterol, and irresponsible prescribing by many physicians."
"Since most patients with chronic asthma can be controlled with inhaled steroids alone, using these more expensive combination formulations as first line is inappropriate but strongly encouraged by marketing practices" of drug makers, Weinberger said.
The products under review are Advair (salmeterol, fluticasone), Foradil (formoterol), Serevent (salmeterol), and Symbicort (formoterol, budesonide). Advair and Symbicort are combination products containing both a long-acting beta agonist and an inhaled corticosteroid. These drugs relax airway muscles, letting asthma patients breathe more easily.
In the panel's first day of hearings Wednesday, FDA officials themselves were split over the risks of the drugs.
One officialtold the panel members that more than 14,000 people may have died since 1994 after taking the drugs, while another suggested that an even greater number might have died without them, according to The New York Times.
Last week, two FDA officials, who work in the agency's safety division, posted an assessment on the agency Web site, saying asthma sufferers of all ages should not take the medicines. But a third FDA official concluded that Advair and Symbicort are safe for adults, but that all four drugs should no longer be used by children 17 and younger, the Times said.
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