Contrave weight loss drug | Modest effectiveness with high risks

Diet pills

Contrave is the latest diet drug to be recommended for FDA approval. Image: Flickr / tacitrequiem / CC-BY

This morning, a Food and Drug Administration review panel recommended that Contrave be approved. Contrave is a weight-loss drug that has shown “modest effectiveness” in helping people lose weight. The FDA panel also voted for additional study of the safety and effects of Contrave.

The effectiveness of Contrave

Contrave is a drug developed by Orexigen Therapeutics out of San Diego. The drug, in studies, had “modest” effectiveness helping overweight individuals drop the weight. Contrave is a combination of two weight loss drugs that have previously been approved, bupropion and naltrexone. By blocking opioid and dopamine receptors, the drugs help limit the pleasure taken out of eating. The drug has been in trials since 2006 and shows about 7 percent better weight loss than diet and exercise programs alone.

The danger of Contrave

Though the panel did vote for the approval of Contrave, the FDA panel also voted 11 to 8 that a larger-scope study should be conducted. The FDA believes that this study can be conducted after the drug is approved and on the market, however. Contrave has shown to increase both blood pressure and pulse rate. These effects could raise the risk of heart attack and stroke in a population already predisposed to those conditions. Orexigen has already conducted some studies, but none were extensive enough to determine heart attack and stroke risk.

Too high a bar for obesity drugs?

The vote to recommend approval of Contrave happened at a complicated time for obesity drugs at the FDA. The same advisory committee suggested that both Qnexa and Lorcaserin, two other wight loss drugs, be denied approval. At the meeting where the advisory panel voted for Contrave, members discussed whether obesity drugs are being held to an unrealistic standard for safety. Given the recalls of multiple drugs recently, the other possibility is that too many drugs are not being held to a high enough standard. What do you think?

Sources

New York Times
Wikipedia

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