FDA to weigh new obesity drug

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For overweight Americans in need of a medically approved way to reach a healthy weight, there may be some welcome news: An FDA advisory committee has recommended the approval of a new weight-loss drug. Yesterday, the Endocrinologic and Metabolic Drugs Advisory Committee voted 20 to 2 to recommend approval of the weight-loss drug Qnexa, which is a combination of phentermine, an appetite suppressant, and topiramate, an anti-seizure medication that increases feelings of fullness.

Phentermine has been used before for weight loss, as one of the ingredients of the weight loss drug fen-phen. Fen-phen was withdrawn in 1996 due to cardiotoxicity, but this toxicity was caused by its other component, fenfluramine not by phentermine.

Qnexa s manufacturer, Vivus, presented studies that demonstrated the drug s ability to reduce patients body weight by 6 to 10 percent; it was also shown to lower blood pressure. Qnexa would be recommended for obese individuals with a BMI (body mass index) of at least 30, or at least 27 when concomitant with other obesity-related conditions such as high blood pressure or diabetes.

The drug has risks as well as benefits, which the panel weighed during their deliberation. As one panel member, Dr. Jessica Henderson pointed out, We can t doubt the benefit of weight loss. But the panel remained concerned about Qnexa s cardiovascular side effects, such as an elevated heartbeat, and the possibility of birth defects oral clefts, in particular. For this reason, the panel did not recommend the drug for use in pregnant women. The panel also recommended that trials following approval of the drug continue to monitor these side effects. The fact that the two components of Qnexa are already available on the market, and can be prescribed off-label for weight-loss, helped to sway the panel s decision in favor of approval.

This would be the first weight-loss drug to be approved in 13 years, notes ACSH's Dr. Gilbert Ross. Since the FDA typically follows the recommendation of the panel, I m eager to see the agency give Qnexa final approval come their decision in April. I think it should have been approved on one of its earlier applications but better late than never.

The more means available to help people lose weight, the better, ACSH s Dr. Ruth Kava adds. While Qnexa may not be right for everyone, it does have the potential to help at least some overweight or obese individuals.