Contrave, A New Weight Loss Drug, Approved by FDA Panel; Is It Heart-Safe?

Lisa Nelson, RD, LN Health Pro
  • An FDA panel consisting of 20 experts voted 13 to 7 in favor of approving the weight loss drug Contrave, with an abstention that additional studies be conducted related to heart risks. Safety concerns were considered, but it was determined that the pros of the medication outweighed the cons. Two weight loss drugs were rejected by the FDA panel just this past October due to safety concerns.

    The weight loss drug Contrave is a combination of the antidepressant buproprion and the anti-addiction drug naltrexone. Some of the side effects reported by the FDA include high blood pressure, dizziness, and insomnia.

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    Contrave studies show patients lost an average of 4.2 percent more weight when using Contrave versus a placebo. This doesn't meet FDA guidelines of at least a 5 percent greater weight loss between obesity drugs compared to a placebo.


    Approximately 35% of adults in the US are obese (weight loss statistics make me picture the movie Wall-E and an entirely obese population unable to walk - what are we heading towards?!) and effective weight loss strategies are needed.


    However, is the answer really in a "magic pill"? Weight loss pills are surrounded with side effects. Abbott Laboratories' pulled their weight loss pill Meridia from the market early 2010 due to risk of heart attacks and strokes.


    The FDA is not required to follow the advice of its expert panels, but often does. We'll see if this new weight loss drug - Contrave - manufactured by Orexigen Therapeutics Inc. is approved by the FDA on January 31st, 2011.


    Scientists at the FDA are concerned over Contrave's effects on the heart, a significant issue when evaluating potential weight loss drugs.


    The medications rejected by the FDA panel in October were linked to potential heart problems, birth defects, and cancerous tumors.


    Just because the FDA panel approved the drug, doesn't mean it'll get the okay from the FDA on January 31st. Over recent years the FDA has been dealing with the backlash of approving medications that end up being recalled due to safety issues.


    Be sure to sign up for 1-a-week weight loss tips provided courtesy of Health Central dietitian Lisa Nelson at

Published On: December 11, 2010