News »June 2007

FDA Panel discards Sanofi-Aventis's Acomplia

June 14, 2007

June 13th proved to be a black Friday for Sanofi-Aventis's diet pill named acomplia as the U.S. Food and Drug Administration (FDA) panel has collectively rejected French Drug maker plea for the approval to sell diet pill Acomplia in the U.S.

The decision is believed to be a direct result of the apprehensions upheld by the agency about the drug's safety right from the beginning.

"The considerations of the panel came down to the very question that all associated hazards are really worth the benefits proffered by the drug, and the final reply to the question came out in negative", said an FDA spokeswoman.

The FDA is scheduled to make a final decision over the drug's approval to be sold in the U.S. in the late July.

"Traditionally, the FDA considers suggestion of the advisory committee while making approval decisions, voiced the spokeswoman.

The drug was voted down by the count of 14-0. Released on June 13th, the panel's report hoisted concerns over the safety of acomplia specifically about its impact on the mental wellbeing. The maker tendered analysis and data on the drug for the evaluation late last year.

"Adverse effects observed whilst drug's clinical trials incorporates anxiety, depression, psychomotor agitation, and sleep disorders," according to the report formulated by the FDA panel.

The FDA's Division of Metabolism and Endocrine Products received several reports of incidences pertaining to side effects of the diet drug acomplia. According to the FDA panel's report, there were 4 reports of delusional symptoms, six of psychotic behavior, and 5 reports of aggression so far".