THURSDAY, Sept. 11, 2014 (HealthDay News) -- A new weight-loss medication has been approved by the U.S. Food and Drug Administration as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.
Contrave is a combination of two already-approved drugs, naltrexone and bupropion, in extended-release form. The medication is approved for use in people with a body mass index (BMI) of 30 or higher, the FDA said in a news release. It also is sanctioned for people with a BMI of 27 or higher who also have at least one weight-related chronic health condition. These conditions include hypertension, dyslipidemia, or type 2 diabetes.
Contrave was evaluated in clinical trials involving some 4,500 obese and overweight people. Results showed that people who took Contrave had an average weight loss of 4.1 percent more than people given a placebo. People who take Contrave should be evaluated after 12 weeks to determine whether treatment has worked, the FDA advised. The drug's label will have a boxed warning of the possibility of suicidal thoughts and behaviors associated with antidepressants. The medication may also cause seizures and should not be used by people with a seizure disorder, the agency added.
The FDA said it ordered a number of post-marketing studies, including evaluations of any cardiovascular risks and of the drug's use among children. Contrave is distributed by Takeda Pharmaceuticals, of Deerfield, Illinois.
More Information
