Heart Risks Spur FDA to Reject Another Diet Pill

The Food and Drug Administration has rejected the weight-loss drug Contrave, dealing a severe blow to a product that stood to be the first diet pill approved by the agency in more than a decade.

Turning aside its advisory panel’s recommendation in December to approve the drug, the FDA cited concern about Contrave’s potential side effects on the heart, particularly with overweight patients taking it for a long period of time.

The FDA left the door slightly open for future approval, however. It told the manufacturer, San Diego-based Orexigen Therapeutics, to go back to the lab and take a more thorough look at the long-term effects of Contrave on the cardiovascular system.

However, many in the pharmaceutical industry were not optimistic. This marks the third weight-loss drug to be given a thumbs-down from the FDA since October, a pattern of denials that led Forbes blogger Matthew Herper to conclude, “The field of obesity drugs is effectively dead.”

As Reuters reports, studies of Contrave by Orexigen found that more than 35 percent of subjects lost 5 percent or more of their total body weight. However, people taking the drug also had a slight increase in blood pressure and pulse, compared with those taking a placebo.

Many industry analysts were predicting an initial short delay by the FDA to request more information, followed by approval and then ongoing study of the drug’s cardiovascular risk.

Related Posts:
FDA Panel Advises Approval of First New Diet Pill in a Decade
Despite Widespread Obesity, Diet Pills Face Tough Scrutiny

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