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Asthma

Advair Complications and Asthma

08/29/2003

Question:

Is the drug Advair life threatening to asthma patients?

Answer:

Advair is a combination of salmeterol and fluticasone. Salmeterol is a long-acting bronchodilator that relaxes the muscles surrounding the bronchial tubes whereas fluticasone is a steroid that suppresses inflammation in the airway. In a recent large study evaluating the safety of salmeterol (13,174 treated vs. 13,179 untreated), there was a small but statistically significant increase in asthma-related deaths or life-threatening episodes in the group taking salmeterol (36 vs. 23 in the placebo group). Although the overall rate of such events was low and the study did not prove that salmeterol use was the cause of these events, the FDA has specified that "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". However, the FDA also notes that based on available data the benefits of salmeterol in the treatment of asthma outweigh the risks when used as directed, and that patients should not stop taking salmeterol or other anti-asthma medications without first consulting their physicians. You can go the FDA web site and use `salmeterol` as a search term to find more information. 

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FDA

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Response by:

Dennis   McGraw, MD Dennis McGraw, MD
Assistant Professor
College of Medicine
University of Cincinnati