A new prescription diet pill has been given clearance by the Food and Drug Administration (FDA) for marketing in the United States. Contrave, made by Orexigen Therapeutics, is a combination of bupropion, an antidepressant that is also used for smoking cessation, and naltrexone, a drug used to treat drug and alcohol dependence.
Contrave is approved for overweight or obese patients with a body mass index (BMI) of 30 or higher, as well as people with a BMI of 27 or higher with at least one other health issue such as diabetes. Patients treated with Contrave lost an average of 4.2 percent of their weight compared to patients treated with a placebo.
The FDA rejected Contrave in 2011, saying more studies were needed to rule out cardiovascular risks. Orexigen resubmitted Contrave last June but the agency postponed its review while the drug company worked out post-marketing obligations relating to the evaluation of cardiovascular risks.
Contrave will carry warnings that it can affect blood pressure and increase the risk for seizures. Patients will also be warned of the risk of suicidal thoughts.
Contrave is the third diet drug to be approved by the FDA. In 2012, the agency approved Vivus Inc.’s Qsymia and Arena Pharmaceutical, Inc.’s Belviq. Both drugs are promoted as lifelong treatments for obesity and have been linked to safety risks including depression and anxiety, heart problems, and birth defects.