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Salmeterol warning cites risk of asthma deaths: add inhaled corticosteroids.(Clinical Rounds)
The labels of three GlaxoSmithKline asthma products containing salmeterol now have boxed warnings citing a "small but significant increase in asthma-related deaths," based on recommendations from the Food and Drug Administration.
The interim results of a study of approximately 29,000 asthma patients in the Salmeterol Multi-Center Asthma Research Trial (SMART) showed more asthma-related deaths and life-threatening asthmatic episodes among African American patients taking salmeterol than among those taking a placebo.
The products with label changes are Serevent Inhalation Aerosol (salmeterol xinafoate), Serevent Diskus (salmeterol xinafoate inhalation powder), and Advair Diskus (fluticasone propionate and salmeterol inhalation powder). Serevent Diskus is approved for treatment of asthma in patients aged 4 years and older, while both Serevent Inhalation Aerosol and Advair Diskus are approved for patients aged 12 years and older.
The "Dear Healthcare Professional" letter included with the products states that patients currently taking these medications should not stop suddenly--this may lead to life-threatening asthmatic episodes due to uncontrolled asthma. In addition, the letter reminds physicians that patients taking salmeterol as their only asthma therapy should add an inhaled corticosteroid to their treatment regimens.
However, the warning implies a much broader problem than exists, Dr. Harold Nelson, professor of medicine at the National Jewish Medical and Research Center, Denver, told this newspaper. The adverse outcomes occurred in patients who were not only African American, but who were not taking inhaled corticosteroids. Those taking inhaled corticosteroids concurrently with salmeterol had no adverse effects, regardless of ethnicity.
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