FDA Adds Warnings to Asthma Drugs |
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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 |
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Greg Monforton and Partners has grown to a highly respected products liability law firm with offices conveniently located throughout Windsor and Essex County, together with affiliate relationships with law firms throughout Ontario, Canada and the United States. We are committed to protecting the rights of individuals injured by defective products. The firm never represents insurance companies or product manufacturers. We only help people. |