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FDA Panel: 3 Asthma Drugs Can Stay

At Issue: Concern That Drugs May Increase Risk of Asthma Attacks
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WebMD Health News

July 13, 2005 -- An FDA advisory panel recommended Wednesday that three popular asthma drugs -- Serevent, Advair, and Foradil -- continue to be sold in U.S. pharmacies.

The FDA often follows the advice of its advisory panels, but it's not required to do so.

All three drugs are long-acting medications. Serevent and Advair contain an active ingredient called salmeterol.

Foradil has a different active ingredient but is in the same class of drugs. Panelists stopped short of recommending a "black box" warning for Foradil, which is the most serious type of warning placed on prescription medications. That type of warning now appears on the labels of Serevent and Advair.

But the panel recommended that Foradil's package insert mention possible safety concerns because Foradil is in the same class of drugs.

Background

In August 2003 the FDA added a black box warning to Serevent and Advair.

At the time, the FDA stated that the warning label for Serevent and Advair was based on a "small but significant increased risk of life-threatening asthma attacks or asthma-related deaths seen in patients taking salmeterol in a recently completed U.S. study."

The 28-week study was halted in January 2003 by Serevent's maker, GlaxoSmithKline.

FDA safety reviewer David Graham, MD, voiced concern about Serevent -- as well as other drugs unrelated to asthma -- during congressional drug safety hearings last November.

The FDA asked for the panel's advice on the topic.

Regulators were concerned that the drug's warnings were not strong or specific enough because of data suggesting that the drug's risks may be higher for blacks.

Today, experts expressed worry about the results in blacks but said they don't have enough evidence to make a more specific warning about the drug. Researchers don't know whether apparent safety differences are due to genetic factors, disparities in access to medical care, or both.

Several experts also said they were reluctant to add a race-based warning that could drive blacks away from the drug.

Doctors' Statements

Speakers at today's meeting voiced some concerns about the class of asthma drugs.

"I have significant concern that it is a class effect," said Steven E. Gay, MD, director of pulmonary and critical care medicine at the University of Michigan Health System and a member of the panel.

"I have concerns that until proven otherwise we have to make ourselves believe that formoterol [Foradil's active ingredient] may act the same way," said Gay.

"The bottom line is we have no idea one way or the other. It's just an unknown whether formoterol would have similar findings or not," said Robert Myers, MD, head of the FDA office responsible for evaluating respiratory drugs.

Drug Companies' Responses

Drug company officials expressed confidence in their products.

Serevent and Advair are both made by GlaxoSmithKline. Foradil is made by Novartis and marketed in the U.S. by Schering-Plough.

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