FDA Warns Obesity Drug May Increase Cardiovascular Events


December 1, 2009

November 21, 2009 – The Food and Drug Administration (FDA) recently announced that it is reviewing data from a study suggesting patients using the drug sibutramine may have a higher number of cardiovascular events than patients using a placebo.

The FDA said the events include an increase in heart attack, stroke, resuscitated cardiac arrest and death. Sibutramine is marketed as Meridia, a prescription drug, in the United States. Meridia was approved by the FDA in 1997 for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with a reduced- calorie diet. The drug is only recommended for obese patients with an initial body mass index (BMI) greater than or equal to 30 kg/m2, or BMI more than or equal to 27 kg/m2, and other risk factors such as diabetes, high cholesterol or controlled high blood pressure.

The data analysis is ongoing and the FDA is making no conclusions about the preliminary findings at this time. These findings highlight the importance of avoiding the use of sibutramine in patients with a history of coronary artery disease (heart disease), congestive heart failure, arrhythmias or stroke, as recommended in the current sibutramine labeling.

For more information: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191655.htm