Washington, Jan. 24 (Reuters): GlaxoSmithKline Plc yesterday said it had halted a study of its already-marketed asthma drug Serevent after seeing more life-threatening asthma episodes, including some deaths, in patients treated with the drug rather than with a placebo.
The US Food and Drug Administration said it would meet the British drugmaker to discuss the trial findings but said the benefits of Serevent continued to outweigh the risks. Patients should not stop taking Serevent without consulting a doctor because abruptly stopping it or other asthma drugs could lead to possibly life-threatening disease flare-ups, the FDA said.
Serevent was launched on the US market in 1994. The halted trial was begun in 1996 to address safety questions about the drug.
London-based GlaxoSmithKline said there were a small number of adverse events in the trial and no conclusions could be drawn from the data.