November 23, 2009
FDA to evaluate risk of cardiovascular events with sibutramineThe FDA has notified healthcare professionals and patients that it is reviewing preliminary data from a recent study suggesting that patients using sibutramine (Meridia, from Abbott) have a higher number of cardiovascular events than patients receiving placebo. The preliminary data shows that cardiovascular events were reported in 11.4% of patients using sibutramine compared to 10% of patients using a placebo. This difference is higher than expected, suggesting that sibutramine is associated with an increased cardiovascular risk in the study population. The study findings highlight the importance of avoiding the use of sibutramine in patients with a history of coronary artery disease, congestive heart failure (CHF), arrhythmias, or stroke, as recommended in the current sibutramine labeling. The analysis of these data is ongoing and the FDA is making no conclusions about the preliminary findings at this time.
Sibutramine is indicated as an adjunct to diet in the management of obesity in patients with initial body mass index ≥30kg/m2, or ≥27kg/m2 in presence of other risk factors.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191655.htm.