FDA Rejects Diet Drug Over Heart Risks

The U.S. Food and Drug Administration has rejected Orexigen Therapeutics' weight-loss drug Contrave. The FDA requested a clinical trial to resolve heart safety concerns, which could take anywhere from two to five years with no guarantee of success.

The setback increased doubts about the drug industry's ability to develop prescription weight-loss drugs. Contrave was the drug thought to have the best chance of approval, after an FDA advisory panel voted 13-7 in favor of the drug in December.

According to Reuters:

"But according to Orexigen, the FDA noted concern about Contrave's cardiovascular effects when used long-term in a population of overweight and obese subjects. The FDA told Orexigen it must conduct a study 'of sufficient size and duration' to demonstrate that the risk of heart attacks, strokes and other major cardiovascular events does not undermine the drug's risk-benefit profile, the company said."

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