Stronger safety warning needed for salmeterol

December 21, 2007

The FDA’s Pediatric Advisory Committee is calling for a strengthened boxed warning on the asthma medication salmeterol (Serevent) to better display the pediatric risks of the drug.

The FDA’s Pediatric Advisory Committee is calling for a strengthened boxed warning on the asthma medication salmeterol (Serevent) to better display the pediatric risks of the drug. The meeting was prompted as a result of nine serious pediatric adverse events (including five patient deaths in children under 16 years old) reported for salmeterol between March 2006 and April 2007. The use of Serevent has declined since reports of asthma-related deaths a few years ago. However, salmeterol is an ingredient in Advair, another asthma drug.

The committee asked the FDA to prominently display a statement in the labeling that recommends use of the drug only as a second-line treatment for asthma. Some members would like to see salmeterol pulled from the market. The panel will meet to review the safety of all drugs in the long-acting beta agonist class in 2008.