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# FDA MedWatch - Meridia (sibutramine): Early Communication about cardiovascular events
- URL: https://www.foodconsumer.org/fda_medwatch_meridia_sibutramine_cardiovascular_events_211120090/
- Published: 2009-11-21T16:21:00.000Z
- Updated: 2026-09-15T12:33:51.000Z
- Description: The FDA told clinicians it is reviewing preliminary data suggesting patients taking sibutramine, sold as Meridia for obesity, had more cardiovascular events than those on placebo. The agency drew no conclusions and restated that the drug should be avoided in patients with heart disease or stroke.
- Author: Food Consumer
- Tags: Government, Health News, #vivvo-import

**Audience**: Cardiology and endocrinology healthcare professionals

FDA notified healthcare professionals and patients that it is reviewing preliminary data from a recent study suggesting that patients using sibutramine have a higher number of cardiovascular events (heart attack, stroke, resuscitated cardiac arrest, or death) than patients using a placebo (sugar pill). Sibutramine is marketed as Meridia, a prescription drug, in the United States. Meridia was approved by FDA in 1997 for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with a reduced calorie diet. Meridia is only recommended for obese patients with an initial body mass index (BMI) ≥ 30 kg/m2, or BMI ≥ 27 kg/m2 with other risk factors (e.g., diabetes, high cholesterol, controlled high blood pressure).The analysis of these data is ongoing and 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 (CHF), arrhythmias, or stroke, as recommended in the current sibutramine labeling.

Read the MedWatch safety summary, including a link to the FDA Early Communication about an Ongoing Safety Review, at:

[http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191655.htm](http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191655.htm?ref=foodconsumer.org)

from FDA