Should the FDA restrict or even withdraw some long-acting asthma meds? That's what the agency is asking an advisory committee to discuss next week, according to an analysis released today. The FDA has sifted the data on a handful of asthma meds--GlaxoSmithKline's Serevent and Advair, Novartis and Schering-Plough's Foradil, and AstraZeneca's Symbicort--and found a link between the drugs and a higher risk of asthma-related side effects.
Already these drugs, known as long acting beta-agonists, carry a "black box" warning that they might boost the risk of asthma-related death. The FDA asked these drugmakers for clinical data on the meds, and that's the data staff just finished checking out. Compared with treatment with other asthma drugs, this class of meds was associated with a greater risk of asthma-related death, asthma-related intubation, and asthma-related hospitalization.
According to Dow Jones, these studies covered 60,954 patients who took part in 110 trials. Some 43,000 of those patients were enrolled in Serevent studies, making it the most worrisome of the drugs, FDA said. Advair, however, appears not to carry the increased risk of complications, the agency said. Both of the drugs are made by GSK, but Advair is its top seller, with $2.9 billion in sales for the first nine months of this year, the AP says.