The Food and Drug Administration (FDA) is evaluating whether regulatory action is needed after receiving reports that some users of the anti-obesity drug Contrave have lost consciousness.
Diet drug Contrave is a combination of two FDA-approved drugs – naltrexone and bupropion. Naltrexone treats alcohol and opioid dependence. Bupropion is used to treat depression and seasonal affective disorder. It is also used to help people quit smoking.
Contrave, which is manufactured by Orexigen Therapeutics, is approved for the use in adults with a body mass index (BMI) of 30 or more, and in adults with a BMI of 27 or more who have at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol. The medication was approved by the FDA in September 2014.
Reports of loss of consciousness in patients treated with Contrave were identified from the FAERS (FDA Adverse Event Reporting System) and reported in the October-December 2016 report Potential Signs of Serious Risks/New Safety Information. The appearance of a drug on this quarterly list does not mean that the FDA has concluded that the drug has the listed risk. It means that the FDA has identified a potential safety issue.
If, after further evaluation the FDA determines that the drug is associated with the risk, the agency may take a variety of actions including requiring changes to the labeling of the drug, requiring the development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering data to better characterize the risk.
Clinical trials used to approved Contrave indicated that the medication can raise blood pressure and heart rate and should not be used in patients with uncontrolled high blood pressure. Other Contrave side effects include nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth and diarrhea.
Any adverse events related to use of this drug should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.