Food and Drug Administration Approves New Weight-Loss Drug for Obese Patients
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September 11, 2014

The U.S. Food and Drug Administration (FDA) Thursday approved a new weight-loss drug for obese and overweight patients.

Contrave in intended to treat adults with a body mass index (BMI) of 30 (obese) or greater or adults who have a BMI of 27 (overweight) and at least one weight-related condition, such as high blood pressure, type 2 diabetes or high cholesterol. Don't throw out your treadmill or whole wheat bread just yet. The medication is to be used in conjunction with diet and exercise.

Contrave is a combination of two FDA-approved drugs, naltrexone and bupropion, in an extended-release formulation. Naltrexone, known as Revia, is approved to treat alcohol and opioid dependence while bupropion treats depression and seasonal affective disorder. Bupropion, commonly known as Wellbutrin, is also used to help patients quit smoking.

According to the Centers for Disease Control and Prevention, more than one-third of adults in the United States are obese.

This is the second time maker Orexigen Therapeutics tried to get approval from the FDA. In 2011, the company was asked to conduct further testing on the drug's cardiovascular risks.

In a clinical trial that included patients without diabetes, users had an average weight loss of about 4 percent over treatment with a placebo one year after the study began. More than 40 percent of patients lost at least 5 percent of their body weight compared to only 17 percent of patients treated with the placebo. In a trial that included those with type 2 diabetes showed patents had an average weight loss of 2 over treatment with placebo after one year. In this trial, 36 percent of patients treated with the drug lost at least 5 percent of their body weight compared to 18 percent who took the placebo.

Clinical trials that included approximately 4,500 obese and overweight patients with and without significant weight-related conditions treated for one year. All patients received lifestyle modification that consisted of a reduced- calorie diet and regular physical activity.

Physicians should evaluate their patients after three months of treatment to determine if it is working. By then users should have lost at least 5 percent of their baseline body weight. If not, it is unlikely that the users will achieve and sustain meaningful weight loss with continued treatment.

Risks and Side Effects

While the drug may help those struggling with obesity, it does come with risks and possible side effects.

Due to the use of bupropion there is an increased risk of suicidal thoughts and other behaviors associated with antidepressants. Those that took the drug to quit smoking have experienced serious neuropsychiatric events.

Since Contrave can cause seizures, it is not acceptable for patients who have seizure disorders. Similarly, it shouldn't be used in patients with uncontrolled high blood pressure. Blood pressure and pulse should be monitored at regular intervals.

Other products containing bupropion should not be taken along with Contrave. The drug should not be used in patients who have eating disorders (bulimia or anorexia nervosa). Contrave should also not be taken by patients who are using opioids or treatments for opioid dependence, or who are experiencing acute opiate withdrawal. Patients undergoing an abrupt discontinuation of alcohol, benzodiazepines, barbiturates and antiepileptic drugs should not take Contrave. Women who are pregnant or trying to become pregnant should not take Contrave.

The most common adverse reactions reported with Contrave include nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea.