FDAnews Drug Daily Bulletin


Nov. 22, 2005

Labeling changes proposed by the FDA to three lucrative asthma drugs are inconsistent with established treatment guidelines and could put patients at increased risk, according to GlaxoSmithKline (GSK), which manufactures two of the medicines.

GSK criticized the FDA recently after the agency publicly requested that manufacturers of long-acting beta 2-adrenergic agonists (LABAs), a class of bronchodilators, update their existing product labeling with new warnings and a medication guide to alert healthcare professionals and patients that these medicines may increase the chance of severe asthma episodes.

LABAs are intended to reduce the frequency of asthma attacks, but clinical data has shown that the drugs may make asthma episodes more severe when they occur, the FDA stated in a public health advisory. In one trial, an increased number of patients taking a LABA in addition to their usual asthma care died from their asthma compared to people taking a placebo, the agency added.

The FDA's request affects three drugs: GSK's Advair (fluticasone propionate/salmeterol xinafoate) and Serevent (salmeterol xinafoate inhalation powder); and Novartis' Foradil (formoterol fumarate inhalation powder), all of which treat asthma by relaxing the muscles around the airways in the lungs.

Among the most controversial of the FDA's recommendations is placing a warning on the drugs' labels that states LABAs should not be the first medicine used to treat asthma. "LABAs should be added to the asthma treatment plan only if other medicines do not control asthma, including the use of low-or-medium dose corticosteroids," the health advisory states.

GSK strongly disagreed with the recommendation, saying that eliminating LABAs as a first-line treatment could put patients at risk of uncontrolled asthma.

"Patient safety is of paramount concern to GSK which is why we disagree with the FDA's proposed labeling changes," said Kathy Rickard, GSK's vice president of clinical development and medical affairs. "These proposed labeling changes would reserve the most effective asthma treatment -- the combination of inhaled corticosteroids and long-acting beta agonists -- until after a patient has failed on other treatment options and therefore may be at risk for severe outcomes, such as exacerbations, and potentially death."

To view the FDA's public health advisory for LABAs, go to http://www.fda.gov/cder/drug/advisory/LABA.htm (http://www.fda.gov/cder/drug/advisory/LABA.htm).