FDA Issues Warning about Some Asthma Drugs

The FDA has issued a warning that some long-acting asthma drugs actually increase the asthma risks they are designed to lessen. The group includes GlaxoSmithKline PLC’s Serevent and Advair, Novartis AG’s and Schering-Plough Corp.’s Foradil and AstraZeneca PLC’s Symbicort. The group of drugs known as long-acting beta-agonists or LBA’s have been under FDA safety review for quite some time because they may increase asthma related death, hospitilization, and intubation. These risks may actually be higher in children. The class of drugs already carry a black box warning but the FDA is considering a stronger move against them if it turns out their analysis of the drugs warrants such action.
The FDA study included 110 trials and 60,954 patients. Serevent studies alone involved 43,000 trials. According to the Wall St. Journal, “Overall, the agency said its analysis showed “that LABAs were associated with an increased risk of asthma-related events relative to non-LABA treatment as measured by the asthma composite endpoint consisting of asthma-related death, asthma-related intubation and asthma-related hospitalizations.”