WEDNESDAY, Feb. 22 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel gave its blessing Wednesday to a highly anticipated weight loss pill that had been rejected by health advisers once before. The committee of outside physicians voted 20-2 to back the drug Qnexa, although the group urged that patients be monitored closely for potential heart problems, the Associated Press reported. A decision by the full FDA is expected in April. The agency typically follows the recommendations of its advisory panels. While effective at reducing weight, the drug, manufactured by Vivus Inc., was denied approval in 2010 because of its potential side effects. Before making its decision Wednesday, the advisory panel reviewed two years of data on the drug; when advisers last voted on Qnexa, only one year's worth of follow-up data was available. The drug combines the appetite suppressant phentermine and the anti-seizure/migraine drug topiramate. Phentermine was once widely prescribed as the "phen" part of the fen-phen weight loss drug. This combo was withdrawn from the market after its use was linked to high blood pressure in the lungs and heart valve disease. The problems were related to the "fen" or fenfluramine part of the combination, not … Continue reading →

Food and Drug Administration advisers voted against the pleas of consumer advocates on Wednesday to recommend approval of what would be the first new diet drug to hit the US market in 13 years. Called Qnexa, the pill is a combination of two older drugs – one itself a diet pill called phentermine, and an anti-seizure drug that appears to help suppress appetite as part of the combination. Such a new drug is desperately needed, with two-thirds of Americans overweight or obese. Current weight-loss products are limited and have only modest effects. But the field has been littered with failures, as many drugs have often deadly side effects – such as the heart valve damage caused by the once popular combination of phentermine and fenfluramine—Fen-Phen for short. Two other companies have diet drugs up for approval too, and the FDA advisers recommended extra studies on the heart effects of all the drugs. “Of all the obesity drugs, this one has the highest efficacy in terms of weight loss, so that shifts the balance in terms of requiring a post-approval study rather than a pre- approval study,” Sanjay Kaul, a cardiologist at UCLA, said at the FDA panel meeting. Public Citizen … Continue reading →

A U.S. Food and Drug Administration Advisory Committee today recommended approval of the weight loss drug Qnexa, a treatment many hope will help millions of Americans who struggle with obesity . In voting  20 to 2 for approval, the committee said today that Qnexa's weight loss benefits for the chronically obese outweighed the risks of birth defects and cardiovascular problems that have been associated with the drug. An FDA advisory panel recommended against approval in 2010 over concerns about the drug's side effects, and the FDA rejected it shortly after that. Vivus, the drug's manufacturer, recently submitted additional research. The committee today recommended that the manufacturer take a number of steps to prevent the drug from causing birth defects like cleft palate, including a possible warning label targeted toward women of childbearing years. The FDA has considered numerous anti-obesity drugs in the past 20 years, but most have failed to meet the agency's standards for safety and effectiveness. But so far, data on Qnexa suggests that the drug is the most effective in helping patients shed up to 10 percent of their body weight. Those changes, along with diet and exercise modifications, could go a long way toward alleviating some of the health … Continue reading →