The Endocrinologic and Metabolic Drugs Advisory Committee met today to discuss the results of the Sibutramine Cardiovascular Outcomes Trial (SCOUT) which evaluated Meridia (sibutramine) in obesity. The study was designed to show that Meridia was more effective than placebo in reducing the number of cardiovascular (CV) events. However, SCOUT actually found that patients using Meridia experienced a higher number of CV events compared to those on placebo.

The committee had a split vote on whether or not to take Meridia off the market. Eight members voted to take it off the market, 6 voted to limit usage through a restricted distribution, and 2 voted for label changes alone.

Included in this PDF document are our analyses of today’s committee meeting and the briefing documents. We also are providing a breakdown of how each panel member voted as well as his/her comments during the discussion session.

For the full report, please download the PDF version at the top of this page.

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