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

Serevent, Foradil should only be used with another medication, in both children and adults, but Advair is spared in advisers' recommendations

THURSDAY, Dec. 11 (HealthDay News) -- The risks of two widely used asthma drugs outweigh their benefits for both children and adults, a U.S. Food and Drug Administration advisory panel said Thursday.

The health panel targeted GlaxoSmithKline's Serevent and Foradil, made jointly by Novartis AG and Schering-Plough, for restrictions, but it excluded Advair, Glaxo's biggest-selling drug in the class of medications known as long-acting beta-agonists. It also left alone a fourth such drug, AstraZeneca's Symbicort.

The health experts did not say that the use of Serevent and Foradil should be abandoned altogether. Instead, they said the medications' labeling should be reworded to urge doctors to use the drugs along with an inhaled corticosteroid -- as guidelines already recommend.

That may help explain why Advair and Symbicort were spared. Serevent contains just one active ingredient, sameterol, while Foradil contains only formoterol. Advair is a combination of both salmeterol and fluticasone (an inhaled cortocosteroid), while Symbicort contains formoterol and another steroid (budesonide). All of these drugs relax airway muscles, letting asthma patients breathe more easily.

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. The results of studies noting a rise in asthma-related deaths by people using the medications have already resulted in a black-box warning that use could "increase the risk of asthma-related death."

The advisory panel voted 10 to 17 on whether the benefits of Serevent outweighed its risk as maintenance therapy for adults, and voted 6 to 21 on the same question for adolescents ages 12 to 17, Dow Jones reported. Foradil r
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