Diet Pill Contrave Rejected by FDA

Weight loss drug Contrave has yet to receive approval from the Food and Drug Administration, which said the product must first address concerns about heart problems in overweight people through further studies.

The FDA said the manufacturer, Orexigen Therapeutics, must hold a double-blind, placebo-controlled clinical trial to demonstrate the risk of major cardiovascular events in people taking the drug.

Contrave contains bupropion, an antidepressant, and naltrexone, a treatment for alcohol and painkiller addiction. The combination of the two drugs has raised concerns for its possible cardiovascular effects, like increasing incidents of heart attacks and strokes.

"Contrave is a combination of two approved drugs that target different parts of the brain influencing appetite and cravings," Dr. Wayne Andersen, the medical director of Take Shape for Life, told AOL Health.

He said existing clinical studies on Contrave showed that it caused blood pressure and heart rate to rise among the control group, a trend that continued after weight was lost.

"They must be used indefinitely or the weight loss is regained," he said. "Any result of the current weight loss drug would require indefinite use with the potential of dangerous side effects."

Orexigen said it was disappointed about the FDA's decision but intends to address the government's concerns.

A much safer way to battle weight gain is to change diet and exercise habits, rather than take pills, Andersen said.

Visit AOL Health to read more about Contrave and its effects.