Contrave

Naltrexone/bupropion

For Weight Loss

Track record

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Short (approved in 2014)

Special FDA warning?

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Yes - FDA requires black box warning

Bottom line

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Weight Loss

What is Weight Loss?

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While a few extra pounds may not seem like a big deal, they can increase your chances of having high blood pressure and high blood sugar. These conditions may lead to serious health problems, including heart disease, stroke, type 2 diabetes, and certain cancers.

Other treatments for Weight Loss

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Non-drug

Over-the-counter

Prescription

TABLE OF CONTENTS

Overview

Bottom Line

Modest benefit

On average people who took Contrave over a year lost about 4 percent more of their body weight compared to those who took a placebo. But, a good number of people—25 percent more—lost 5 percent or more of their weight from taking Contrave, compared to those who took a placebo. Contrave didn't work as well in people with diabetes. Contrave hasn't been shown to reduce serious health problems of obesity like heart attacks or strokes.

Serious side effects

Some people who were manic or depressed before become manic or depressed again; severe, potentially fatal skin reactions (blisters, peeling rash, mouth ulcers), including Steven-Johnson Syndrome; potentially fatal liver failure; and serious eye problems (angle-closure glaucoma). When used with diabetes medications, Contrave can cause low blood sugar.

Symptom side effects

The most common side effect is nausea. Other common side effects are vomiting, constipation, headache, and dizziness. In the most recent trial done after approval, 27 percent of people had to stop Contrave because of side effects, compared to 7 percent who took a placebo.

FDA-approved use

For weight loss for adults - Contrave should be used in combination with a reduced calorie diet and increased exercise

FDA recommends you stop Contrave if you have not lost 5% or more of your body weight after 12 weeks on the drug

Who might consider taking it?

Adults who are overweight or obese

Adults who are overweight (Body Mass Index (BMI) of 27 to 29.9) with a weight-related problem (high blood pressure, high cholesterol, or heart disease) or are obese (BMI of 30 or higher)

What is not known

It is not known if Contrave changes your chance of heart problems or stroke or of death due to heart problems or stroke

Not tested with other prescription, over-the-counter, or herbal weight loss products

Track record

SHORT TRACK RECORD

Short track record for this use means that new, unexpected side effects are possible. The ingredients in Contrave were first approved by FDA in 1984 (Naltrexone for opioid addiction) and 1985 (Bupropion for depression). They were only approved as a combination for weight loss in 2014 based on studies in which about 2,500 people took approved doses of the drug for a year. As with all drugs, important side effects may emerge when larger numbers of people with other conditions and on other medication take this new drug combination for a longer time than the time frame of the trials.

Open questions

Ongoing studies FDA required to answer questions about harms

FDA required the company to conduct a trial in obese and overweight people with heart disease or other risk factors to understand if Contrave increased the risk of heart attacks, strokes or heart problems. Early results suggested that a large increase was unlikely. But because the company released information preliminarily, the FDA required a new trial.

Do not take if you...

Have uncontrolled high blood pressure

Have a seizure disorder or history of seizures

Because of an increased chance of seizures

Have or have had anorexia or bulimia

Anorexia (eating very little) or bulimia (eating too much and vomiting to avoid gaining weight) may increase your chance of seizures

Take benzodiazepines or barbiturates regularly and suddenly stop taking them

This increases your chance of seizures.

Take medications for seizures and suddenly stop them

This increases your chance of seizures.

Drink a lot of alcohol and abruptly stopping drinking

Because of an increased chance of seizures

Take other medicines that contain the drug bupropion

Because of an increased chance of seizures. Other bupropion-containing products include Wellbutrin, Wellbutrin SR, Wellbutrin XL, and Aplenzin.

Are dependent on opioid pain medicines, use medicines to help stop taking opioids, or are in opiate withdrawal

Because of a chance of opioid overdose. Opioid medications include hydrocodone combined with acetaminophen (Vicodin) and oxycodone (Oxycontin), as well as opioid prescription cough and cold products. Methadone or buprenorphine are examples of medicines to help stop taking opioids.

Take monoamine oxidase inhibitors (MAOIs)

Because of an increased chance of high blood pressure. Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including linezolid. Do not start Contrave until you have stopped taking your MAOI for at least 14 days.

Are allergic to Contrave or its ingredients

Are pregnant or planning to become pregnant

Because weight loss offers no potential benefit to a pregnant woman and may harm the fetus. Tell your healthcare provider right away if you become pregnant while taking Contrave.

Safe if pregnant or breastfeeding?

Pregnant

Do not take: Controlled human studies show Contrave harms baby and potential benefits do not outweigh potential harms (FDA Category X)

Breastfeeding

Not recommended - Contrave gets into breast milk

NEXT: TRIALS

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