Asthma Drug May Be Deadlier for Blacks
Study Led to 'Black Box' Warning for Serevent After Respiratory-Related Deaths
Jan. 12, 2006 -- Serevent, a widely prescribed inhaled asthma treatment, may pose a special risk to blacks.
Newly released details from a safety trial that was stopped early reveal that respiratory-related deaths or life-threatening events occurred four times as often among blacks who took Serevent than among blacks who did not take the drug.
There was no significant difference in deaths or serious adverse outcomes among whites who did and did not take the asthma drug, which is manufactured by GlaxoSmithKline, a WebMD sponsor.
The findings, first reported to the U.S. Food and Drug Administration in 2003, led the regulatory agency to require a black-box warning on the labeling for Serevent and the similar GlaxoSmithKline asthma drug Advair.
The warning notes that use of the drug in the study led to a "small but significant increase in asthma-related deaths." A separate box also states, "Data from this study further suggests that the risk might be greater in African-American patients."
Thirteen deaths occurred among 13,176 study participants treated with Serevent for 28 weeks, compared with three deaths among 13, 179 participants who did not take the drug.
Seven of the 13 deaths in the Serevent arm of the study involved blacks, even though blacks made up just 18% of the total study population.
Both Serevent and Advair contain the active ingredient salmeterol, but Advair also contains an inhaled corticosteroid. Results from the Salmeterol Multicenter Asthma Research Trial (SMART) appear in the January issue of the journal Chest.