среда, 11 августа 2010 г.

FDA Panel Says 'No' to Weight Loss Drug Qnexa

July 15, 2010 -- Don't approve Qnexa for , an FDA expert advisory panel today said in a 10-6 vote. The FDA usually follows the recommendation of its advisory panel, but the split vote, and some of the comments by panelists, may leave the FDA room to approve the drug. It may cause , it may increase suicide risk, it can cause a condition called metabolic acidosis that speeds bone loss, it increases risk of , and may have other serious effects. "They were not strongly against the drug but had lingering concerns that made them vote 'no.'" Qnexa is a combination of low doses of two drugs already on the market: the amphetamine and the seizure drug . It's targeted for use only by patients and in overweight people with a BMI of 27 or more plus a weight-associated condition such as , , or . But panelists worried that millions of people struggling with their weight will want to give the drug a try. Phentermine is the "phen" half of the failed weight-loss drug fen-phen, although that drug's heart toxicity was almost entirely due to its "fen" half. For safety reasons, this drug should not be approved," Wolfe told the panel.

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