Salmeterol — A Word of Caution from the FDA

Salmeterol may have an unfavorable risk-benefit ratio in the treatment of pediatric asthma.

In October 2007, the FDA released the following statement in a postmarketing adverse event review of salmeterol: “Accordingly, we conclude that salmeterol may have an unfavorable risk-benefit ratio in the treatment of pediatric asthma. We recommend a more thoroughgoing, formal risk-benefit analysis of salmeterol in the treatment of pediatric asthma.” This conclusion was based on the following information:

Nine cases of serious adverse events (5 fatalities) in children ages 0 to 16 years reported in the Adverse Event Reporting System (AERS) database during a 13-month period (3 cases were attributed to misuse of Serevent Diskus).
A fourfold increase in the number of deaths among salmeterol recipients in the placebo-controlled Salmeterol Multice…

Author

Howard Bauchner, MD

Disclosures

Grant / research supportHuman Resources and Services Administration; NIH; NIH-NHLBI; USDA; GlaxoSmithKline

Editorial boardsArchives of Disease in Childhood (Editor-in-Chief)

Howard Bauchner, MD

Disclosures

Grant / research supportHuman Resources and Services Administration; NIH; NIH-NHLBI; USDA; GlaxoSmithKline

Editorial boardsArchives of Disease in Childhood (Editor-in-Chief)