Two Asthma Meds May Be Too Risky, FDA Panel Says
Thursday, December 11, 2008; 12:00 AM
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, salmeterol, 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 received 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.