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FDA Approves New Diet Pill But DEA Has To Approve Dosage Levels First Before It Can Be Sold

Posted Jun 27 2012 8:16pm

Why does the DEA have to approve?  The drug is in a category for potential abuse.  Belviq works on activating a receptor in the brain, serotonin that helps you forget about wanting to eat.  Theimage concern here is the similarity with the drug fen-phen that was pulled from the market as it had potential heart issues and side effects.  It’s a gradual loss and in trials people lost about 6 percent of their body weight after a year.  I don’t know, that’s doesn’t sound like a lot and I think I could do better with teaching myself when to push away from the table or have my jaw wired shut if I were needing to lose weight.  I think the jury is still somewhat out on this one until it is actually prescribed and we get more information.  BD


 

The first new prescription diet pill in 13 years won approval from the Food and Drug Administration on Wednesday, providing a new option for the roughly one-third of American adults considered obese.

Before Belviq’s approval, there was only one prescription medicine — Roche’s Xenical — approved for long-term use in weight loss.

The history of diet pills has been marked by many safety problems, which has made the F.D.A. reluctant to approve new drugs. Belviq itself was turned down by the agency in 2010, but Arena came back with new data that assuaged some of the agency’s safety concerns.

Belviq works by activating a receptor in the brain, called serotonin 2C, in a way that helps suppress appetite.

The main safety concern about Belviq is that it works somewhat similarly to fenfluramine, a drug that was part of the popular fen-phen diet pill combination. It and a similar drug called dexfenfluramine were withdrawn from the market in 1997 after they were found to damage heart valves.

http://www.nytimes.com/2012/06/28/health/diet-drug-gains-fda-endorsement.html


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