FDA Warns Serevent May Increase Chances of Serious Attack
Friday, January 24th, 2003Source: Washington Post
The Food and Drug Administration announced that Serevent, a widely used asthma medicine made by GlaxoSmithKline, could increase the risk of a serious or fatal asthma attack in a few people who use it. According to a recent study, the risk appears to be greatest in African Americans and patients who are not also taking an inhaled corticosteroid drug for their asthma. The study was launched because of earlier concerns over the safety of Serevent, whose chemical name is salmeterol.
The FDA said Serevent remains a useful drug for most asthma patients.
“We still feel that from the data at hand that this drug is safe and effective,” said Robert J. Meyer, one of the FDA’s directors of drug evaluation. “But if part of what we are seeing is because the drug is not being used as part of a well-thought-out asthma care plan, then it behooves us to emphasize . . . that it really does need to be used in that setting.”
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