Serevent Inhalation Aerosol and Diskus (salmeterol xinafoate)
Audience: Pulmonary specialists and other healthcare professionalsThe FDA announced the addition of new safety information and warnings to the labeling for drug products that contain salmeterol, a long-acting bronchodilator used to treat asthma and chronic obstructive pulmonary disease (COPD). The new labeling includes a boxed warning about a small, but significant, increased risk of life-threatening asthma episodes or asthma-related deaths observed in patients taking salmeterol in a recently completed large U.S. safety study.
[August 2003 Letter - GlaxoSmithKline]
[August 14, 2003 Talk Paper - FDA]
[August 2003 Revised label, Serevent - GlaxoSmithKline]
[August 2003 Revised label, Serevent Diskus - GlaxoSmithKline]
[August 2003 Revised label, Advair Diskus - GlaxoSmithKline]