Experts Consider Withdrawal of 3 Asthma Drugs

An FDA advisory panel is discussing today the safety -- and possible withdrawal from the market -- of three asthma drugs: Serevent, Advair, and Foradil.

A recommendation by the expert panel is expected to be made later today. The FDA would then consider the recommendation when making its final decision.

Asthma patients should not stop taking their asthma medications without talking to their doctor. Abruptly stopping asthma medication can result in an asthma attack.

Serevent, Advair Labels Changed in 2003

In August 2003, the FDA added a "black box" warning to Serevent and Advair. This is the most serious type of warning placed on prescription medications.

At the time, the FDA stated that the warning label for Serevent and Advair is based on a small but significant increased risk of life-threatening asthma attacks or asthma-related deaths seen in patients taking salmeterol, an active ingredient in both drugs.

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

Serevent Mentioned by FDA Scientist

In November 2004, Serevent was one of five drugs singled out by FDA scientist David Graham in testimony before the U.S. Senate.

Graham voiced concerns about the safety of those five drugs - only one of which, Serevent, treats asthma.

The FDA has been investigating Graham's concerns.

Class of Drugs

Serevent and Advair contain an ingredient called salmeterol. Advair also contains a steroid drug that fights inflammation.

Salmeterol is a long-acting bronchodilator, which means it helps keep airways open for a longer time. It's part of a class of drugs called long-acting beta-agonists. These drugs are used to prevent asthma attacks, not treat them, as they don't work immediately.

Foradil, which did not get a "black box" warning from the FDA in 2003, contains a different long-acting beta-agonist.

Response From Maker of Serevent and Advair

GlaxoSmithKline makes Serevent and Advair. The company is a WebMD sponsor.

"Clearly, we feel that Serevent is a very important treatment for asthma and other respiratory conditions, and the information related to asthma in the context of safety has been fully reviewed by the [FDA] and incorporated into labeling at earlier points in time," GlaxoSmithKline spokeswoman Lisa Behrens tells WebMD.

"We think there is complete information about the product to prescribers so they can make informed decisions," she continues.

"Additionally, we feel that Serevent has a very favorable benefit-to-risk profile and is a highly effective bronchodilator that's a valuable option," says Behrens.

"I would say, of course, exactly the same thing for Advair," she says, calling both products "highly effective treatments."

"Data related to Serevent ... has had a very comprehensive review by the [FDA] and is approved as a safe and effective medication for asthma," says Behrens.

"It's important that if patients would have any questions, they should consult with their doctor and make sure that they're getting those questions answered. But again, there has been an extensive review and the benefits of the drug continue to be very favorable and outweigh risk," she says.

Response From Foradil Maker

Foradil is made by Novartis, a WebMD sponsor. It is marketed in the U.S. by Schering-Plough Corporation.

"Long-acting beta-2 agonists are part of an established treatment for asthma," Schering-Plough spokeswoman Julie Lux tells WebMD.

"The safety of Foradil for the treatment of asthma ... is supported by an extensive safety analysis of data based on clinical studies involving over 8,500 patients treated with Foradil, and spontaneous reports representing over 13 million person-years of exposure worldwide since 1990," says Lux.

By Miranda Hitti, reviewed by Michael W. Smith, MD

SOURCES: Associated Press. WebMD Medical News: "FDA Issues Warning for Serevent, Advair."WebMD Medical News: "Safety Concerns Halt Asthma Drug Study." WebMD Medical News: "FDA Scientist Concerned About Five Drugs on Market." Lisa Behrens, spokeswoman, GlaxoSmithKline. Julie Lux, spokeswoman, Schering-Plough.