The FDA shot down Sanofi-Aventis' hopes of bringing the drug to the U.S. market, where weight-loss pills have become a major industry. The FDA, which typically follows its panel's advice will make a final decision on the drug by the end of July.
If Acomplia, known generically as rimonabant, were approved in the U.S. market, the drug would likely be called Zimulti because the FDA rejected the brand name of Acomplia.
Dr. Jules Hirsch, a senior physician at New York's Rockefeller University told AP, "There is a reasonable suspicion we better learn some more and watch this affair more closely before we launch into massive use of this drug."
Nearly 14 voting members said additional safety information should be required before the FDA should consider approving the drug, which was approved for use by European health authorities last June.
The drug is currently being sold in 18 countries and the company claims it can help patients lose an average of 15 pounds. Rimonabant is designed to help block a chemical in the endocannabinoid system - a physiological system in the body that is believed to play a role in how the body regulates food intake.
According to a new report by the FDA, the blockage of the same chemical can also put the user at risk for psychiatric problems and could increase the risk for neurodegenerative disorders such as multiple sclerosis.
