FDA refuses to approve another diet drug
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.
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.
The setbacks come as public health experts are alarmed about the number of Americans who are overweight and obese, which increases the risk for a host of health problems, including heart attacks, strokes, diabetes and cancer.
The FDA's actions have prompted criticism from some obesity experts, who argue that the agency is holding diet drugs to too high a standard. They say the FDA should be willing to accept some risks from the drugs, given the health hazards of obesity But others say that any new diet pill is likely to be used by large numbers of people, which means even rare side effects would be worrisome.
| October 29, 2010; 10:37 AM ET
Categories: Cardiovascular Health, Childhood obesity, Obesity
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