TUESDAY, Dec. 7 (HealthDay News) -- An expert advisory panel recommended on Tuesday that Contrave, a new weight-loss pill that combines an antidepressant with an anti-addiction medication, be approved by the U.S. Food and Drug Administration.
The 13-7 vote in favor of Contrave came amid agency concerns that the drug might raise blood pressure in some patients and increase the risk of heart attacks and strokes among some users, according to the Associated Press. But panelists voted 11-8 earlier in the day that those potential health risks could be studied after Contrave was approved.
The FDA does not have to follow the advice of its advisory committees, but it typically does. The agency is expected to make a decision on Contrave by Jan. 31, the wire service reported.
Contrave is manufactured by Orexigen Therapeutics Inc. In October, the FDA voted against approving two other weight-loss drugs, Arena Pharmaceuticals' lorcaserin and Vivus' Qnexa, because of safety concerns, according to the AP.
Last July, a study funded by Orexigen and published in The Lancet found that Contrave helped users shed pounds when taken along with a healthy diet and exercise.
People who took the drug for more than a year lost an average of 5 percent or more of body weight, depending on the dose used, the team said.
However, the regimen did come with side effects, and about half of study participants dropped out before completing a year of treatment.
Contrave is combination of two well-known drugs, naltrexone (Revia, used to fight addictions) and the antidepressant bupropion (known by a number of names, including Wellbutrin). The drug appears to boost weight loss by changing the workings of the body's central nervous system, the researchers said.
The study enrolled men (15 percent) and women (85 percent) from around the country, ranging in age from 18 to 65. They were all either obese or overweight
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