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FDA Weighs Fate of Qnexa for Weight Loss, Again
Date:2/21/2012

By Denise Mann
HealthDay Reporter

TUESDAY, Feb. 21 (HealthDay News) -- The U.S. Food and Drug Administration plans to take a second look at the weight loss pill Qnexa on Wednesday, after initially rejecting it because of concerns about heart problems and possible birth defects.

While effective at reducing weight, the drug, manufactured by Vivus Inc., was denied approval in 2010 because of its potential side effects. An FDA advisory panel will now review two years of data; when advisers last voted on Qnexa, only one year's worth of follow-up data was available.

The drug combines the appetite suppressant phentermine and the anti-seizure/migraine drug topiramate. Phentermine was once widely prescribed as the "phen" part of the fen-phen weight loss drug. This combo was withdrawn from the market after its use was linked to high blood pressure in the lungs and heart valve disease. The problems were related to the "fen" or fenfluramine part of the combination, not the phentermine.

No new weight-loss drug has been approved in the United States in the past 13 years, according to published reports. As it stands, Xenical is the only FDA-approved drug specifically for long-term use -- up to a year -- for weight loss. Xenical is sold over-the-counter as Alli. However, other drugs may be used off label to promote weight loss.

Last April, a study funded by Vivus found that obese patients taking Qnexa lost an average 22 pounds over a year, while also lowering their blood pressure and cholesterol levels.

Dr. Louis Aronne, founder and director of the Comprehensive Weight Control Program at New York-Presbyterian Hospital/Weill Cornell Medical Center in New York City, is cautiously optimistic that Vivus did a good job responding to FDA safety concerns, and that the FDA will give the drug its nod of approval, with some caveats. Aronne was not involved in the trials but has been an adviser to Vivus and other companies d
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