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ZimultiAcompliaReport
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Your INDEPENDENT source of news about diet drug Acomplia / Zimulti (Rimonabant) | |||||||||||||||||||||||||||||||
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| Acomplia / Zimulti (Rimonabant) Side Effects | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
While Acomplia has been approved for sale in Europe, uncertainties remain about rimonabant's side effects. Researcher Luc Van Gaal of the University Hospital in Antwerp, Belgium, said 14.5 percent of patients participating in one of the large clinical trials who were on the 20 mg dose stopped taking Acomplia due to adverse side effects. The main side effect, he said, was nausea, which affected one in eight patients. An earlier clinical trial also had a drop-out rate due to side effects of about 15 percent. Probably the most objective and comprehensive evaluation of side effects available at the moment is the one published as part of the approval process by European Medicines Agency (EMEA). This was its report. ACOMPLIA 20 mg has been evaluated for safety in approximately 2,500 patients enrolled in studies that examined the metabolic and weight loss effects in overweight and obese patients and in approximately 3,800 patients in other indications. In placebo-controlled studies, the discontinuation rate due to adverse reactions was 15.7 % for patients receiving rimonabant. The most common adverse reactions resulting in discontinuation were: nausea, mood alteration with depressive symptoms, depressive disorders, anxiety and dizziness. Depressive disorders were reported in 3.2% of obese patients, or overweight patients with associated risk factor(s) treated with rimonabant 20 mg. These were usually mild or moderate in severity and resulted in recovery in all cases either after corrective treatment or discontinuation of rimonabant and did not exhibit any differentiating characteristics compared to cases reported in the control groups. The following table shows all treatment-emergent adverse reactions from four placebo-controlled studies in patients treated for weight loss and related metabolic disorders when these incidences were statistically significantly greater than the corresponding placebo rate (for events greater than or equal to 1 %) or considered clinically relevant (for events fewer than 1 %). Classification of expected frequencies of undesirable effects: Very common (More than 10 out of 100); Common (More than 1 in 100 but fewer than 10 in 100); Uncommon (More than 1 in 1,000 but fewer than 1 in 100); Rare (More than 1 in 10,000 but fewer than 1 in 1,000); Very rare (Fewer than 1 in 10,000), Not known (cannot be established from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
In clinical studies for other indications, the following additional adverse reactions were commonly reported: − infections and infestations: sinusitis − metabolism and nutrition disorders: anorexia, decreased appetite − nervous system disorders: disturbance in attention − gastrointestinal disorders: stomach discomfort, dry mouth. |
We subscribe to the HONcode principles of the HON Foundation. This is an independent news site reporting on rimonabant, a diet drug developed by Sanofi-Aventis Inc., which is marketing it in Europe under the trademarked name Acomplia and in the United States under the trademarked name Zimulti.. Nothing on this site is intended to infringe on that trademark. Nothing on this site is intended as medical advice. The information provided here is for informational purposes only. Always consult a doctor or medical professional with questions you may have regarding a medical condition.
(c) 2004-2006 Medical Week News, Inc. All Rights Reserved
Last Updated: 05/08/2007