August 9, 2004 GlaxoSmithKline Plc’s asthma drugs Serevent and Advair will carry new warnings about a small risk of life-threatening asthma episodes or asthma-related deaths, the Food and Drug Administration said Thursday.
The FDA, in a statement, said the benefits of treating patients with Serevent or Advair continue to outweigh the risks when used according to instructions.
Both drugs contain an active ingredient called salmeterol, a long-acting beta agonist that relaxes the bronchial muscles and allows patients to breathe more easily.
Serevent was launched on the U.S. market in 1994, and the company started a study of it in 1996 to address safety questions.
In January, GlaxoSmithKline announced it had halted the Serevent trial after seeing more life-threatening asthma episodes, including deaths, in patients treated with the drug rather than a placebo.
Patients should not stop taking either Advair or Serevent without consulting a doctor because abruptly stopping it could lead to possibly life-threatening disease flare-ups, the FDA said.
Officials at GlaxoSmithKline were not immediately available for comment.