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    FDA Advisers Recommend New Diet Drug

    By Maggie Fox | National Journal – Wed, Feb 22, 2012

    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.”

     

    2 comments

    • Emilyrose2005
      Emilyrose2005  •  Highland Park, New Jersey  •  3 mths ago
      Well, yet again, the pockets of FDA have been thickly lined by a pharmaceutical company. This is the drug containig topiramate (Brand:Topamax). Google this dangerous drug BEFORE ASKING FOR A SCRIPT! Take it from someone who became suicidal after just 3 days on that hideous drug! There are already class-action lawsuits against it.
      Please, the FDA are all corrupt - look out for YOURSELVES to stay healthy.
    • startover
      startover  •  3 mths ago
      i havent noticed 2/3'ds of americans obese.and a pill to fix fat people will never work.yea some people have eating disorders but they can still function in society,the rest of them need exercise and awareness of what they are doing to themselves.all the new drugs work for a while then kill you with the side effects.human testing is the only way to see if they work.
     Post a comment
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