SILVER SPRING, Md. — A federal advisory panel on Thursday narrowly recommended approval for U.S. sales of the first new anti-obesity drug in more than two decades.
The panel for the Food and Drug Administration voted, 6 to 5, to recommend allowing Interneuron Pharmaceuticals Inc. to market the drug, dexfenfluramine. The FDA usually acts favorably on the recommendations of its panels.
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% of patients in a study lose up to 10% of their body weight. The drug works by altering the brain chemical serotonin to make people feel full even though they have eaten less.
While the panel recommended approving the drug, it said post-marketing studies should be conducted to determine any adverse long-term effects. Panel members also said they want labels on prescriptions to include language warning that studies have not determined the long-term effects.
The last anti-obesity drug to gain government approval was fenfluramine, in 1973. But it can be prescribed only for short-term use.