FDA Releases Update of Its Safety Review of Meridia

The FDA has notified healthcare professionals and patients that it is reviewing preliminary data from a recent study of Meridia (sibutramine).
This data suggests that patients taking Meridia have a higher number of cardiovascular events, including heart attack, stroke, resuscitated cardiac arrest or death, than patients using a placebo.

Meridia won FDA approval in 1997 to manage obesity, facilitate weight loss and maintain weight loss in conjunction with a reduced calorie diet. The medication is only recommended for obese patients with an initial body mass index (BMI) of greater than or equal to 30 or a BMI of greater than or equal to 27 accompanied with other risk factors, such as diabetes, high cholesterol and controlled high blood pressure.

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

More information about the safety review is available on the FDA's Web site.

Contact:
FDA
800-332-1088