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Rimonabant linked to depression, anxiety

Executive Summary

A meta-analysis of four pivotal trials for Sanofi-Aventis' Zimulti, published in the Nov. 17 issue of the Lancet, shows that patients receiving rimonabant were 2.5 times more likely than those on placebo to discontinue treatment because of depressive mood disorders and three times more likely to discontinue because of anxiety. The analysis of the four RIO studies by Robin Christensen, Frederiksberg Hospital, et al., concludes that rimonabant increases the risk of psychiatric adverse events and that greater attention needs to be paid to the potential of rimonabant to induce depressive symptoms in obese patients. An FDA analysis of Zimulti clinical data has also shown an increase in suicidality for the novel agent (1"The Pink Sheet" June 25, 2007, p. 23). Based on rimonabant's psychiatric and neurological profile, FDA's Endocrinologic and Metabolic Drugs Advisory Committee unanimously concluded that more detailed safety information in larger patient numbers over the long term is needed before the drug could be approved, and Sanofi subsequently withdrew its NDA...
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