Panel Endorses Anti-Obesity Drug

A federal advisory panel on Thursday narrowly recommended approval for sale in the United States of the first new anti-obesity drug in more than two decades.

The panel for the Food and Drug Administration voted 6-5 to recommend allowing Interneuron Pharmaceuticals Inc. to market the drug, dexfenfluramine.

The FDA usually acts favorably on the recommendations of its scientific panels, but their was no immediate indication when the agency would act.

The drug has been available for sale in 65 countries for the past 10 years, but the U.S. panel of experts was concerned about possible adverse side effects of taking the drug over a long period of time.

At the September panel meeting, Interneuron Pharmaceuticals said its dexfenfluramine helped 40 percent of patients in a study lose up to 10 percent of their body weight, twice the amount lost with diet alone.

The drug works by altering the brain chemical serotonin to make people feel full even though they have eaten less.

The panel’s chairman, Dr. Henry Bone of Detroit, Mich., voted against the recommendation. Bone said more long-term studies were needed to determine whether dexfenfluramine causes widespread hypertension, one of the side-effects seen in a small number of patients.

“We are talking about an unrestrained usage,” Bone said. “Of concern to me is that we have very little information about the long-term effects of this drug.”

But Dr. Nemat Borhani of the University of California, a panel member who voted in favor, said, “The only thing I care about is that it helps people lose weight.”