There's more bad news for those hoping for new drugs to help fight the obesity epidemic: The Food and Drug Administration has refused to approve yet another new diet pill. The agency sent a letter to the drugmaker raising a variety of concerns about Qnexa, according to Vivus Inc., of Mountain View, Calif., which had sought the drug's approval. The letter does not bode well for the drug winning approval.
The move was expected, given that an FDA advisory panel had voted against the drug's approval in July because of evidence it may have adverse side effects, including increasing the risks for birth defects during pregnancy.
But the step is the latest in a series of setbacks in the effort to develop new weight-loss drugs. The FDA last week rejected approval of lorcaserin because of it appeared to cause tumors in rats. And earlier this month the agency forced the removal of the the drug Meridia from the market because it appears to increase the risk for heart attacks and strokes.
A Roche Holding AG's Accutane acne pill package, Pfizer's Bextra painkiller and Abbott Laboratories' weight-loss drug Meridia in a pharmacy in Wilmette, Illinois in 2004. Meridia is one of three diet pills rejected this month by the FDA. (Tannen Maury/Bloomberg News)
Despite millions of dollars in research, only a handful of government-approved weight-loss drugs remain on the market. Only one can be used long term, and none is considered very effective. The last time the FDA approved a new diet drug was in 1999.
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