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Advair, Serevent add "black box"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

GlaxoSmithKline's asthma treatments Advair Diskus (fluticasone/salmeterol) and Serevent (salmeterol) labeling is revised to include "black box" warnings on an increased risk of asthma-related deaths in salmeterol-treated patients. Warnings for both products state that patients receiving salmeterol on top of a usual asthma regimen "showed a small but significant increase in asthma-related deaths" vs. placebo, an Aug. 14 FDA "Talk Paper" states. The effect was more pronounced in African American patients. The finding comes from GSK's Salmeterol Multicenter Asthma Research Trial (SMART); the firm alerted physicians in January that it had halted the study due to the findings and enrollment difficulties. "It is not known whether the findings seen with Serevent…would apply to Advair," Advair's labeling states. FDA is considering the possibility of a beta agonist class effect...
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