Warnings on Qsymia
Weight-Loss Drug Qnexa Under FDA Safety Review
After rejecting the weight-loss drug Qnexa in 2010, the Food and Drug Administration is examining new data to determine whether the drug should be approved.
By Annie Hauser
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FRIDAY, Feb. 17, 2012 —Next week, the Food and Drug Administration is set to review the safety and effectiveness of the controversial weight-loss drug Qnexa, whose manufacturers, Vivius Inc., are pushing to make Qnexa the first new FDA-approved weight-loss supplement since 1999.
The FDA originally reviewed Qnexa as a treatment for weight loss in 2010, but turned it down over safety concerns, including possible heart problems and an increased risk of birth defects. , other studies of one of Qnexa’s active ingredients, topirmate, have suggested an increased birth-defect risk. In response, Vivius initially proposed limiting the drug to men and women of nonchild-bearing age.
After the initial rejection, the FDA asked Vivus for an additional assessment of the drug’s potential harm — a common practice in FDA drug proceedings — and now, Vivus reports the drug is not only safe, but also effective in producing significant weight loss. Next week’s review of the drug will include data from a two-year clinical trial, as opposed to only one year’s worth of data, which was what was reviewed in 2010. The new clinical trial data found that the drug was successful in producing weight loss during the first year of use, but that some participants did regain some weight during the second year of the trial.
The 2010 rejection of Qnexa and several other diet drugs thrust the FDA’s approval process for weight-loss drugs into the spotlight at a time when obesity continues to be a nationwide health crisis. In recent years, the agency has been particularly hesitant to approve new treatments because of missteps with past approvals, including most infamously, the diet drug cocktail fen-phen, which was later found to cause potentially fatal heart-valve problems.
Video: Qnexa, a New Weight Loss Drug, Reviewed by FDA
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