FDA Advisers Recommend New Diet Drug

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 objected.

“Public health cannot tolerate yet another drug approval for a diet drug not accurately assessed for cardiovascular risks, especially in light of suggestive findings of such risks with Qnexa,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “The danger of another approved diet drug hitting something vital – the cardiovascular system – is no longer acceptable when it could be prevented by a large clinical trial powered to evaluate such risk prior to approval.”

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FDA Advisers Recommend New Diet Drug