FDA panel recommends warning on salmeterol

A US Food and Drug Adminstration advisory panel has recommended that three popular asthma drugs should get label warnings about their potential risk to children, according to the Wall Street Journal on-line.

The FDA plans to conduct a safety review of UK drug major GlaxoSmithKline's Advair (fluticasone propionate/salmeterol) and Serevent (salmeterol), as well as Foradil (formoterol fumarate), originated by Switzerland's Novartis and sold in the USA by local drug major Schering-Plough, after clinical data from two studies showed increased mortality in patients taking the long-acting beta agonist salmeterol, which belongs to the same drug class as formoterol, the active ingredient in Foradil.

The WSJ noted that, in one of the two evaluations, the death rate was 0.1% out of a 12,176-strong trial population, but only 0.02% for placebo. The FDA panel recommended that the manufacturers should add warnings to the labels that are specific to children and stated they may increase the chance of asthma-related hospitalizations. The agency usually follows the advice of its advisory committees.