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Acomplia (rimonabant) : Psychiatric side effects reported by 43% of patients vs 28% with placebo
Wednesday, April 02, 2008 6:50 am Email this article
"Significant psychiatric and gastrointestinal tract adverse effects were observed [ in people given 20 mg of Acomplia ( rimonabant ) ] but were usually mild or moderate in severity," noted the authors of the STRADIVARIUS study that involved 839 patients at 112 centers in North America, Europe, and Australia.
A total of 43.4 percent of those given Acomplia ( rimonabant ) reported psychiatric side effects versus 28.4 percent of those given a placebo.
"These adverse events consisted primarily of an increase in anxiety and depression," the authors noted. Patients with History of Psychiatric Disorders Not Excluded
People with a history of psychiatric disorders were not excluded
“To assess the safety of rimonabant in a broad population, the study intentionally did not exclude patients with a prior history of psychiatric disorders,” the paper noted.
Not For Sale in US
Acomplia is available in other countries, but not US
Acomplia ( rimonabant ), “which is available in several countries but has not yet been approved by the US Food and Drug Administration (FDA). In June 2007, an FDA panel did not recommend approval of rimonabant pending clarification of safety issues, primarily psychiatric adverse effects, including anxiety and depression.”
Nissen SE, Nicholls SJ, Wolski K, Rodes-Cabau J, Cannon CP, Deanfield JE, Despres J-P, Kastelein JJP, Steinhubl SR, Kapadia S, Yasin M, Ruzyllo W, Gaudin C, Job B, Hu B, Bhatt DL, Lincoff AM, Tuzcu EM. Effect of rimonabant on progression of atherosclerosis in patients with abdominal obesity and coronary artery disease. JAMA. 2008 Apr 2, 299(13):1547-60.
AUTHOR’S CONTACT INFORMATION
Steven E. Nissen, MD
Department of Cardiovascular Medicine
Cleveland Clinic Foundation
9500 Euclid Ave
Cleveland, OH 44195 USA
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