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

eveloping weight loss medications.

"I am not as pessimistic as most people," he said.

Vivus has reported that Qnexa may increase the risk of cleft lip in babies of women who use the drug while pregnant. Aronne said the birth defect concern could be addressed through education on who should and should not use the new drug.

"We have learned our lessons with weight loss drugs," he said. "They need to be used in the right people under the right circumstances." The heart risks need to be weighed against reductions in heart disease risk factors that come with weight loss, he said.

Qnexa is not any riskier than bariatric surgery, according to Aronne. "The problem is that it can be distributed more widely," he said. He hopes for a compromise that allows the new compound to be prescribed, but not misused. "Once new medications are approved, local medical boards will need to enforce rules and make sure these medications are prescribed appropriately to the right candidates," he said. "We don't want to open up pill mills."

One thing is clear, he said: More options to treat obesity are needed. "For hypertension, there are 120 medications in nine categories," Aronne said. "We need new options and we need to get physicians thinking about obesity and obesity treatments."

Dr. Scott Kahan, an obesity expert at Johns Hopkins University in Baltimore and director of the National Center for Weight and Wellness in Washington, D.C., agreed. He is optimistic about the FDA's upcoming decision on Qnexa. "The weight loss effects are striking and approaching the amount of weight loss over two years that we get with bariatric surgery," he said. "This is really impressive."

More information

Learn more about weight loss medications at the U.S. National Institutes of Health.

SOURCES: Louis Aronne, M.D., founder and director, Co
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