Contrave was approved by the FDA September 2014. It is a combination of the alcohol and opioid dependence treatment naltrexone hydrochloride and the antidepressant bupropion hydrochloride. Contrave is intended as a treatment option for chronic weight management in obese patients (those with a BMI of 30 or greater) or overweight patients (those with a BMI of 27 or greater) who have at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol.
The two new adverse events – loss of consciousness and abuse – were identified during a postmarket review by scientists with the FDA’s Office of Surveillance and Epidemiology and Office of New Drugs in the Center for Drug Evaluation and Research (CDER). These postmarket reviews are preformed 18 months after a drug’s approval or after its use by 10,000 individuals, whichever is later.
Loss of consciousness is currently listed on Contrave’s safety label as a possible consequence of overdose. The label also currently states that the drug has not been systematically studied in humans for its potential for abuse and that clinical trials revealed no evidence of physical dependence of abuse. “Findings in clinical trials, however, are not known to reliably predict the abuse potential of drugs,” the label states.
The evaluations are done to determine if there are any new serious adverse events not previously identified during product development, known side effects reported in unusual number, or potential new safety concerns now that the products are being used in the general population.
While many of the medications reviewed are not associated with new side effects, those that are flagged are continuously reviewed to determine whether regulatory action is required.
Any adverse events related to use of Contrave should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.