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FDA Panel Split on Meridia

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Washington, DCThe expert panel that convened to evaluate data on Abbott's diet drug Meridia was unable to come to a decision regarding whether or not the drug should stay on the market.

The 16 members of the Endocrinologic and Metabolic Drugs Advisory Committee were split down the middle – with eight members voting the keep the drug on the market provided certain new restrictions were put in place, while the other eight members voted to remove the drug from the market based on evidence which shows that the risks for cardiovascular events outweigh the benefits from potential weight loss.

Cardiovascular adverse events associated with the use of Meridia were discovered in patients participating in the six-year SCOUT (Sibutramine Cardiovascular Outcomes) trial. Data showed a 16 percent increased risk for cardiovascular events in patients taking Meridia, compared with those on placebo. The difference was statistically significant.

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