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U.S. Department of Health and Human Services

Safety

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Serevent Inhalation Aerosol and Diskus (salmeterol xinafoate)

Audience: Pulmonary specialists and other healthcare professionals

The 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 2003 - Revised label, Serevent - GlaxoSmithKline]
[August 2003 - Revised label, Serevent Diskus - GlaxoSmithKline]
[August 2003 - Revised label, Advair Diskus - GlaxoSmithKline]