September 11, 2014
In September 2014, the U.S. Food and Drug Administration (FDA) approved naltrexone hydrochloride and bupropion hydrochloride extended-release tablets (Contrave) for chronic weight management. Contrave is used in combination with lifestyle changes, such as a healthy, reduced-calorie diet and regular exercise program.
This weight-loss medication is approved for adults over the age of 18 with clinical obesityindicated by a body mass index (BMI) of 30 or higherand adults classified as overweightthose with a BMI of 27㪵who also have at least one weight-related medical condition, such as type 2 diabetes, hypertension (high blood pressure), or high cholesterol. Using the body mass index, the Centers for Disease Control and Prevention (CDC) estimates that more than one-third of adults in the United States are obese and are at high risk for a number of health problems.
Contrave is an extended-release combination drug. It contains naltrexonealso approved to treat substance dependenceand bupropionapproved to treat depression, seasonal affective disorder (SAD), and as a smoking cessation aid.
A number of clinical trials involving Contrave have been conductedone study in people without diabetes showed that 42 percent of those taking the medication for 1 year lost at least 5 percent of their body weight, compared with 17 percent of those who took a placebo. In another study involving people with type 2 diabetes, 36 percent of those taking Contrave lost at least 5 percent of their overall body weight in 1 year, compared to 18 percent of people taking a placebo.
According to the FDA, people who take Contrave should be evaluated after 12 weeks of treatment. Those who have not lost at least 5 percent of their total body weight should talk to their health care provider about discontinuing the drug, as it is unlikely to be effective in these individuals.
Contrave Side Effects
Contrave carries as boxed warning that bupropion may increase the risk for suicidal thoughts and actions and neuropsychiatric events such as mood changes and hallucinations. The FDA cautions that other medications containing bupropion should not be taken along with Contrave. This weight-loss medication should not be used in people who have seizure disorders (epilepsy), uncontrolled high blood pressure, or eating disorders (anorexia nervosa, bulimia); in women who are pregnant or trying to become pregnant; or in those who take opioids or are undergoing treatment for opioid dependence.
Common side effects of Contrave include the following:
- Constipation, diarrhea
- Dry mouth
- Insomnia (difficulty falling or staying asleep)
- Increased heart rate and blood pressure (pulse and BP should be monitored during treatment)
- Nausea and vomiting
- Seizures (dose-related risk)
Following approval of the drug, the FDA announced a number of post-marketing requirements to further evaluate the safety and effectiveness of the weight-loss drug Contrave. These studies and clinical trials include:
- Cardiovascular outcomes trial
- 2 pediatric studies (one involving children 7 to 11 years of age, and one involving adolescents 12 to 17)
- Clinical trial to assess dosing in people with impaired liver or kidney function
- Clinical trial to determine if Contrave interacts with other medications
- Study with juvenile animals to evaluate the drug’s effect on growth and development, behavior, learning, and memory
Source: U.S. Food and Drug Administration (FDA)