The U.S. Food and Drug Administration panel finally aired its view about acomplia, a weight-loss drug formulated by the French drug maker Sanofi-Aventis. On June 13th, the FDA’s panel rejected the maker’s plea to approve the drug to be marketed and sold in the Untied States on the basis of safety concerns.
An FDA spokeswoman said that the panels’ deliberations reached to the notion that risks associated with the drug’s usage are not really worth its benefits and thus the panel’s final response was pessimistic.
The FDA will take up a final decision over acomplia’s approval for sale in the U.S. in the late July. Traditionally, the FDA considers suggestions furnished by its advisory committee while making any approval verdict. During the voting, acomplia approval was shot down by the score of 14-0.
The report formulated by the FDA and released on Wednesday has evoked concerns over the safety of the drug, essentially about its impact on consumer’s mental fitness. Paris-based drug maker provided data for its product review last year.
During the clinical trials, the drug has shown many adverse effects on human health. The encountered side effects include depression, anxiety, sleep disorders and psychomotor agitation.
The FDA’s Division of Metabolism and Endocrine Products is also laden with many reports related to the worse effects of acomplia. According to the report, there were 4 incidents of delusional symptoms, 5 cases of aggression and 6 episodes of psychotic behavior.
Rimonabant, a generic equivalent of acomplia is approved in 37 countries and can be marketed in 18 countries, as per the estimate of Sanofi-Aventis.
Tags: Acomplia, Diet pills ., Lose weight, Weight loss programs
