Qnexa Ruling Renews Debate About Its Risks and Benefits


Qnexa is a combination of two drugs already approved by the FDA: phentermine, a stimulant that suppresses appetite, and topiramate, a drug used to treat migraines and epilepsy that has weight loss as a side effect. Vivus recommends that the drug be prescribed as a part of weight loss plans that include diet and exercise.

Clinical trials so far show that the drug helps people shed 10 percent of their body weight, although patients regained some weight in the second year on the drug. It also seemed to have positive effects on blood sugar and blood pressure.

"I believe that this combination is different and a significant advance from any agents used in the past for weight loss," said Dr. Chip Lavie, medical director of cardiac rehab and prevention at the Ochsner Clinic Foundation in New Orleans. "Considering the dismal results that many experience with attempted weight loss with diet and exercise, which is always the first choice, and the explosion in the need and use of bariatric surgery, this combination drug should be a major advance."

The FDA will decide whether or not to approve Qnexa by April 17. Although the agency usually follows the recommendations of its panels, the drug's fate is not assured. In 2011, a panel recommended the weight loss drug Contrave for approval, but the FDA declined to follow its advice.

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