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Asthma
Labeling changes required for drug products that contain salmeterol
September 1st, 2003
The U.S. Food and Drug Administration (FDA) is announcing 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 products affected by these changes are Serevent Inhalation Aerosol, Serevent Diskus, and Advair Diskus. The new labeling for these products will contain 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. On January 23, 2003,...
Source: Health & Medicine Week (2003-09-01)
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