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FDA Ongoing Safety Review of Meridia

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Published at: www.fda.gov

William HaynesDirector of Clinical PharmacologyTHE UNIVERSITY OF IOWA

New Meridia SCOUT Trial has Major Implications for Obesity Drug Development

November 23, 2009

The recent FDA release of preliminary data from the first large-scale, randomized, cardiovascular outcome trial ever conducted for the treatment of obesity comes as a shock. While full data are not available (and the level statistical significance was not given), the fact that cardiovascular events increased rather than decreased with an obesity treatment that is at least moderately effective in reducing weight is an unwelcome surprise. Major changes in FDA review of new obesity drugs may occur.