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FDA Reconsiders Weight Loss Drug Qnexa

Weight Loss Impressive, but Safety Questions Remain
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Tough Times for Weight Loss Drugs continued...

Last October, in the same month that the first Qnexa application was rejected, the FDA also rejected Arena Pharmaceuticals’ application for its weight loss drug lorcaserin for safety reasons . The agency also forced the withdrawal of the diet drug Meridia from the market after 13 years, citing concerns about heart attack and stroke risk.

Weight loss specialist Louis Aronne, MD, of Weill Medical College at Cornell University, says the FDA may feel pressure to approve Qnexa because it is effective, as long as the company shows that it can limit its use to those for whom it is approved.

Aronne directs the Comprehensive Weight Control Program at New York-Presbyterian Hospital.

"Obesity is a huge and growing medical problem and we need effective drugs to treat it," he tells WebMD.

He says just as weight loss surgery is now considered more of a medical than cosmetic procedure, a new generation of weight loss drugs will be thought of in the same way.

"This is not a cosmetic issue, it is a medical one," he says. “Weight loss has all kinds of health benefits, including improving blood pressure, diabetes, sleep apnea, and stroke and heart attack risk."

Bariatric surgeon Mitchell Roslin, MD, agrees, but he tells WebMD that his concerns about Qnexa remain. Roslin is chief of obesity surgery at Lenox Hill Hospital in New York City.

"We don’t know if this drug is safe enough for patients to stay on it to maintain their weight loss," he says. "It clearly works better than other drugs out there, but the questions remain -- at what cost and for how long?”

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