WARNING Data from a large placebo-controlled US study that compared the safety of salmeterol (SEREVENT Inhalation Aerosol) or placebo added to usual asthma therapy showed a small but significant increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,174 patients treated for 28 weeks) versus those on placebo (4 of 13,179). Subgroup analyses suggest the risk may be greater in African-American patients compared to Caucasians (see WARNINGS and CLINICAL PHARMACOLOGY: Clinical Trials: Asthma: Salmeterol Multi-center Asthma Research Trial). | ||||
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