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Contrave® FDA-Approved for Weight Loss

Darrell Hulisz, RPh, PhamD
Tristan Maiers, Doc

December 3, 2014

The FDA recently approved Contrave®, a combination product consisting of naltrexone and bupropion extended-release tablets. This represents another novel treatment option in chronic weight management. The approved specifically is as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of ???30 kg/m2 or ???27 kg/m2 in the presence of at least one weight-related comorbid condition, such as hypertension, type 2 diabetes mellitus, and/or dyslipidemia. Naltrexone is an opioid antagonist approved to treat alcohol and opioid dependence, while bupropion is a dopamine reuptake inhibitor approved for the treatment of depression, seasonal affective disorder, and nicotine dependence. Patients using Contrave® at the maintenance dose should be evaluated every 12 weeks to see if the patient has lost at least 5% of baseline body weight. If not, the drug should be discontinued; as it is unlikely the patient will achieve and sustain a clinically significant weight loss with further treatment.

Since Contrave® contains the antidepressant bupropion, the product has a black boxed warning for increased risk of suicidal thoughts and behaviors in children, adolescents & young, as is the case for other antidepressants. However, the drug is not likely to be used in the pediatric population. Serious, but uncommon side effects include dose-related seizure activity, increased blood pressure and, and increased heart rate. Other adverse reactions include nausea, vomiting, constipation, diarrhea, headache, insomnia, and dry mouth. It is contraindicated in patients who have seizure disorders, eating disorders, those using treatments for opioid dependence, or experiencing acute opioid withdrawal, or undergoing discontinuation of alcohol, benzodiazepines, barbituates, or antiepileptic drugs, and in pregnancy.

FDA News Release. FDA approves weight-management drug Contrave. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm413896.htmAccessed on November 19, 2014.

Lexi-Comp, Lexi-Drugs Online®. Retrieved from http://online.lexi.com Hudson, OH: Lexi-Comp, Inc. Accessed on November 19, 2014.

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