Contrave: FDA Panel Okays Diet Drug Critics Call Risky

(CBS/AP) Americans hungry for a new weight loss drug got some good news on Tuesday, when an FDA advisory panel recommended that the agency approve a new drug called Contrave.

The agency doesn't have to follow the panel's recommendation but often does. It is scheduled to make a decision on Contrave by Jan. 31.

Weight-loss drugs haven't had much luck with the FDA in recent months. In October, the agency rejected the drugs lorcaserin and Qnexa over safety concerns.

There are also concerns about Contrave.

Scientists are concerned about the drug's effect on the heart, an issue that has weighed heavy on potential weight loss drugs. Complaints focused on the company's lack of elderly patients with a history of heart disease in clinical trials. That lack of data made it difficult to determine the drug's safety in patients at risk for heart attack and stroke.

Contrave is a combination pill, mixing the antidepressant bupropion with the anti-addiction drug naltrexone. FDA reported higher rates of side effects already linked to the drugs, including high blood pressure, dizziness and insomnia.

Studies showed that patients taking the drug, on average, lost 4.2 percent more weight than patients taking a placebo. Those results did not meet an FDA guideline that there should be at least a 5 percent difference in weight loss between the groups. The drug did meet a second measure of effectiveness involving the number of patients who lost at least 5 percent or more of their weight.

In a statement ahead of the panel vote, Dr. Sidney Wolfe, director of Public Citizen's health research group, said the FDA should eventually reject Contrave because of safety concerns.

"The diet pill Contrave is the latest in a long line of dangerous and, ultimately, failed weight loss drugs," he said in a statement, citing drugs that have been pulled from the market, including fen-phen.

He said his main concern with Contrave is the potential for heart-related side effects. Part of the drug's formula, bupropion, is already known to increase blood pressure.

But weighing a drug's risks versus its benefits isn't easy, especially since obesity rates in the U.S. are near 35 percent among adults and physicians and health officials have said new weight-loss therapies are desperately needed.

Couldn't we all just cut back on calories and start exercising more?

Fat chance.