Weight Loss News

Diet Drug Acomplia Smacked by the FDA Panel's Refusal

June 14, 2007

June 13th may proved an auspicious day for millions, but for the French drug maker Sanofi-Aventis's acomplia, undoubtedly not as the U.S. Food and Drug Administration panel collectively refused to grant approval to the drug for sale in the United States on the date. On Wednesday, the FDA's advisory panel rejected Acomplia, a weight-loss medicine, on the basis of the safety issues associated with its usage.

"The panel's deliberations reached to the fact that the possible risks are not worth the profits offered by the drug and thus the panel responded in the negative" said an FDA spokeswoman.

The final decision on the drug's approval will be taken up by the FDA in late July. Acomplia, also extensively recognized as Rimonabant, was beaten up by the difference of 14-0.

"Traditionally, the FDA looks upon the recommendations furnished by the advisory committee while taking up approval decisions," added the spokeswoman.

Yet Paris-based Sanofi-Aventis announced late Wednesday that it will continue to cooperate closely with the FDA regulations and will take initiatives to tackle the committee's recommendations."

In a report primed by the advisory panel, several concerns were winched up about the safety of the weight-loss drug, predominantly about its upshots on psychological health. Sanofi-Aventis provided data on Acomplia for review to the panel last year.

"Adverse events experienced by the most test subjects during the drug's clinical trials include depression, anxiety, sleep disorder and psychomotor agitation," as per the report of the panel.

The FDA's Division of Metabolism and Endocrine Products has also encountered many reports revolving around Acomplia's side effects. According to the report, "There were 4 reports of delusional symptoms, 6 reports of psychotic behavior and 5 reports of aggression".