Meridia was approved by the Food and Drug Administration as an appetite-suppressant drug 14 years ago. Now an advisory committee of the FDA will meet to determine if Meridia should stay on the market. The reassessment of Meridia (sibutramine) is being conducted following the SCOUT trial, which is published in the New England Journal of Medicine (NEJM). It finds that Meridia increases the risk of heart attacks and stroke. With this new information, the panel will be asked whether the drug should be re-reviewed for approval.
Abbott Laboratories makes Meridia. The FDA advisory panel will meet September 15 to review the SCOUT trial outcome which found more than 11 percent of those who took Meridia suffered a heart attack or stroke compared with 10 percent on the placebo.
European regulators have already pulled the drug from store shelves. But this is the U.S. and Meridia is expected to generate $100 million in profit for Abbott this year. It has long been questioned why the drug remained on the market for fourteen years given that trial participants lost an average of just over nine pounds during a six-year study.
Steven Nissen of the Cleveland Clinic says with the risks considered, Meridia has more risks than benefits. Public Citizen’s Sidney Wolfe wonders why the drug remains on the market. Even the researchers of the study conclude the drug should continue to be available under prescription but with a strong warning for people who’ve had a heart attack or stroke.
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