FDA Panel Rules: Two Popular Asthma Drugs Risky, Advair and Symbicort Safe

By Alice Carver
10:47, December 14th 2008
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FDA Panel Rules: Two Popular Asthma Drugs Risky, Advair and Symbicort Safe

A Food and Drug Administration panel said Thursday that the risk of taking the asthma medications Serevent and Foradil generally outweighs the benefits of the drugs when they are not prescribed along with steroids. Serevent is a combination of an inhaled corticosteroid and the long-acting beta agonist (LABA) Serevent. The labels of these medications mention that doctors should prescribe them along with steroids, but only a half of patients who take them also get a prescription for steroids. Taking a LABA alone, without a steroid, seems to increase the risk of death and serious asthma attacks in some patients.

The panel strongly recommends that the commonly prescribed asthma medications Serevent and Foradil no longer be used as a standalone asthma treatment in adults, adolescents or children because they have serious side effects and they provide few benefits over simple steroid treatment. In a 17-to-10 vote, the panel said the risks of long-term Serevent and Foradil use outweigh the benefits when used alone. The vote, however, doesn’t mean that the drugs will be pulled from the market, but the experts concluded that the drugs’ labels should be changed to warn about the risk.

At the same time, the panel ruled that two other asthma drugs, Advair and Symbicort are safe in adults because they contain a combination of beta-agonist and steroid drugs, which makes them less risky.

The U.S. Food and Drug Administration will consider the panel’s recommendations.

Serevent and Advair are made by GlaxoSmithKline, Foradil is made by Novartis, and Symbicort is made by AstraZeneca.



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