FDA approves weight-loss drug Contrave

Howard LeWine, M.D.
Howard LeWine, M.D., Chief Medical Editor, Internet Publishing, Harvard Health Publications

For the third time in two years, the FDA has approved a drug to help people lose weight. The new drug, Contrave, combines two generic drugs, naltrexone and bupropion.

Naltrexone is used to help kick an addiction to alcohol or narcotics. Bupropion is used to treat depression and seasonal affective disorder. Many people also take bupropion to stop smoking. Neither naltrexone nor bupropion by itself has been approved for weight loss.

“When used as directed in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, Contrave provides another treatment option for chronic weight management,” said Dr. Jean-Marc Guettier, director of the division of metabolism and endocrinology products in the FDA’s Center for Drug Evaluation and Research, in a press release.

Specifically, Contrave was approved for use by adults who are obese (meaning a body-mass index of 30 or higher) and by overweight adults (body-mass index between 27 and 30) who have at least one other weight-related condition or illness, such as high blood pressure or type 2 diabetes. (Don’t know your body-mass index? Calculate it using Harvard Health Publications BMI calculator.)

Contrave joins Belviq (lorcaserin) which the FDA approved in June 2012, and Qsymia, which got the green light a month later. Neither of those two drugs has sold well. Pharmacies will likely have Contrave in stock within a few months.

Does Contrave work?

The FDA approved Contrave based on the results of several clinical trials that included 4,500 overweight and obese men and women. Some had significant weight-related conditions, others didn’t. All were treated for one year.

In one trial of people without diabetes, 42% of those who took Contrave lost at least 5% of their body weight, compared with 17% of those who took a placebo. In a trial of people with diabetes, 36% of those taking Contrave lost at least 5% of their body weight, compared with 18 % of those taking a placebo.

Across the studies, some people lost much more than 5% of their body weight. But it’s important to note that more than 50% had minimal or no weight loss.

If Contrave does not work after 12 weeks, the FDA says its use should be stopped.

How does it work?

Why should the combination of a drug for addiction and one for depression help with weight loss? It’s likely that the drugs act on impulse, reward, and/or hunger centers in the brain to decrease appetite and dampen the reflex to seek food for comfort.

Downsides of Contrave

Like any drug, Contrave can cause unwanted side effects. These include

  • nausea and vomiting
  • constipation
  • headache
  • dizziness
  • insomnia
  • dry mouth
  • diarrhea
  • elevated blood pressure and heart rate
  • seizures

Since the use of bupropion has been linked to the onset of suicidal thoughts, Contrave will carry the same black-box warning about this that bupropion does. Naltrexone use has been linked to seizures.

Given the side effects and warnings, Contrave shouldn’t be taken by anyone with

  • a seizure disorder
  • uncontrolled high blood pressure
  • an eating disorder
  • a narcotic addiction or who is taking medication to treat one.

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    This is great news for people who really need a boost in their weight loss journey. Of course it should be used in conjunction with a good diet and exercise program.

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  9. Dr Puneet Chandna

    Contrave has contraindications too. best way to loose way is the healthy and workout way.

  10. letty

    Will contrave come in the generic form? It’s made from 2generic drugs. The only way medicade pays for this drug if its generic

  11. Maher

    Contrave, a new weight-loss drug currently in clinical trials, is a combination of Wellbutrin and the addiction drug Naltrexone. According to Dr. Dennis Kim, senior vice president of medical affairs and communications at Orexigen Therapeutics Inc., the makers of Contrave, in an article for ABC News, people taking the drug lost an average of 8 percent of their body weight, around 17 pounds, within one year. As of June 2009, the drug was not yet approved by the F.D.A. Said Kim, “We have clearly cleared the hurdle, the efficacy benchmark, it’s of course the FDA’s judgment to see if it passes for safety.”

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  12. Rainbow

    Finding new drugs is great and there are chronic wait issues that may need a drug, but the weight issues are bigger than mere drug treatment. It is a corporate issue what’s mixed in our food, all the marketing for junk food. One has to be responsible for themselves, take charge know what they are eating and being aware of our eating habits is very important. It doesn’t happen overnight but it will happen if we keep doing it everyday.

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