This article is from the WebMD Medical News Archive

Date of alert: Aug. 14, 2003

What is alerted: The FDA has added new safety information and warnings to the labeling for drug products containing salmeterol -- a long-acting bronchodilator used to treat asthma and emphysema. Products affected by these changes are Serevent Inhalation Aerosol, Serevent Diskus, and Advair Diskus.

New precautions: New labeling will contain a boxed warning about a small but significant increased risk of life-threatening asthma attacks or asthma-related deaths seen in patients taking salmeterol in a recently completed U.S. safety study.

Basis of alert: Based on the results of a 28-week study that compared effects of salmeterol in asthma patients with asthma patients not taking the drug. African Americans, in particular, had a significantly higher risk of having a life-threatening asthma attack or asthma-related death when taking Serevent.

Manufacturer: GlaxoSmithKline.

SOURCE: FDA.