April 5th, 2012

Diet drug Qnexa awaits FDA OK amid safety concerns

By Nanci Hellmich

Some things may indeed look better the second time around, but why would that be the case for a new diet drug that’s poised to become the first such drug approved by the Food and Drug Administration in more than a decade?

The proposed prescription medication Qnexa (kyoo-nek-suh) from Vivus Inc. of Mountain View, Calif., helps dieters lose 10% of their weight when used in combination with diet and exercise.

Yet it was rejected on a 10-6 vote the first time it came before a government advisory panel, in 2010, because of safety concerns. But when the medication returned for another review in February, the advisory committee gave it near-unanimous approval (20-2). Because the FDA often follows the advisory panel’s advice, Qnexa is likely to get FDA approval, probably by mid-April.

But Sidney Wolfe, director of the health research group at Public Citizen, a consumer group, says that the risks outweigh the benefits. “We are strongly opposed to approving it. This idea that there is a magic bullet that will knock your hunger out, but not do other kinds of damage, is ridiculous.”

He thinks the advisory committee approved the diet drug because members “felt there was a desperate need for a new diet drug even though many other ones had come and gone because of safety concerns.”

Read more: http://www.usatoday.com/news/health/story/2012-04-04/Qnexa-diet-drug-approval/54005412/1


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