On September 10th 2014, the U.S. Food and Drug Administration (FDA) announced the approval of Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets). Contrave received the FDA's approval for treating chronic weight management in addition to reduced-calorie diet and exercise.
The FDA said that Contrave had been approved for use in obese adults (BMI of 30 or over) or overweight adults (BMI of 27 or over) with at least one weight-related condition such as high blood pressure, type 2 diabetes, or elevated cholesterol.
The FDA advises patients who take the newest drug, Contrave, to be closely monitored and reevaluated after 12 weeks. If the patient has not lost at least least 5 percent of their body weight, its use should be discontinued.
The FDA warns that because it contains an anti-depressant, bupropion, there are risks of increased suicidal thoughts and behaviors that are usually associated with those types of drugs. And there are even reported neuro-psychiatric events associated with bupropion in patients using it as a smoking cessation aid.
Contrave can cause seizures and must not be used in patients who have seizure disorders. The risk of seizure is dose-related. Contrave should be discontinued and not restarted in patients who experience a seizure while being treated with Contrave.