FDA decision means Serevent, Advair, and Foradil to remain on market

September 1, 2005

A Food and Drug Administration advisory committee recommended in July that Serevent (salmeterol), Advair (fluticasone propionate/salmeterol), and Foradil (formoterol) be kept on the market, despite safety concerns. The committee, which had convened in response to an FDA request to consider withdrawal of those drugs, did, however, call for the addition of a black box warning to Foradil.

A Food and Drug Administration advisory committee recommended in July that Serevent (salmeterol), Advair (fluticasone propionate/salmeterol), and Foradil (formoterol) be kept on the market, despite safety concerns. The committee, which had convened in response to an FDA request to consider withdrawal of those drugs, did, however, call for the addition of a black box warning to Foradil.

A black box warning was added to GlaxoSmithKline's Serevent and Advair in 2003, based on data showing an increased risk—particularly among African-Americans—of asthma death or life-threatening event with salmeterol compared to placebo. In recommending the black box labeling for Novartis's Foradil, the committee said that the warning should mention the asthma-related deaths seen with Serevent, but that it should explicitly state that this effect has not been established with Foradil.

The committee found that the benefits of salmeterol in asthma control justify keeping it on the market. The medication came under fire last November when Associate Director of Science for the FDA's Office of Drug Safety, David Graham, MD, questioned the safety of Serevent and five other medications during a Congressional hearing on Merck's Vioxx (rofecoxib).

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