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Two Asthma Meds May Be Too Risky, FDA Panel Says
Date:12/11/2008

eceived similar votes on the same questions: 9 to 18 for adults and 6 to 21 for adults.

The panelists were unanimous in voting that the benefits of the two drugs did not outweigh risks when used for children ages 11 and younger.

The announcement followed a two-day meeting on the issue by the expert advisory panel. The FDA is not obligated to follow the advice of its advisory panels but usually does so.

Speaking before Thursday's decision, one expert said 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.

In the panel's first day of hearings on Wednesday, FDA officials themselves were split over the risks of the drugs.

One official told 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.

The panel was reviewing an FDA study of 110 trials that included 60,954 people and found an increase in
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