FDA Raises Safety Concerns For Vivus Diet Pill

By: Associated Press
By: Associated Press

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Friday, February 17, 2012

Federal health officials continue to voice safety concerns over an experimental diet pill from drugmaker Vivus Inc., which will make its second attempt to convince experts of the drugs' safety next week.

The Food and Drug Administration previously rejected the diet pill Qnexa in October 2010. Now Vivus has resubmitted the drug with additional follow-up information, hoping for a more favorable review.

But in documents posted online Friday, the FDA reiterated concerns about two safety issues: Potential heart problems and birth defects in women who become pregnant while taking the drug.

On Wednesday the FDA will ask an outside panel of experts whether Qnexa appears safe and effective. The group's recommendation is not binding, and the FDA is expected to make its final decision in April.


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