Safety Alerts & Recalls

What does this mean?

Although the FDA is still reviewing the SCOUT study results, the current 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 (abnormal heart rhythms), or stroke, as recommended in the current sibutramine prescribing information. If you are taking sibutramine (or the brand Meridia) and you have a history of heart problems, you should follow up with your doctor and review the benefits and risks of continuing this medicine.

Until more information becomes available, all patients taking sibutramine (or the brand Meridia) should watch for signs of cardiovascular events and seek medical attention right away if any of them occur. Warning signs of a heart attack include chest pain or chest discomfort, pain or discomfort in other areas of the upper body (including one or both arms, the back, neck, jaw or stomach), shortness of breath, breaking out in a cold sweat, nausea, dizziness or lightheadedness. Early signs of a stroke include numbness or weakness of the face, arm or leg, especially on one side of the body; confusion, trouble speaking or understanding; trouble seeing in one or both eyes; trouble walking, dizziness, loss of balance or coordination; and severe headache with no known cause.

If you have any questions about this safety alert or if you are experiencing side effects from sibutramine, please follow up with your doctor.

FDA Early Communication About Ongoing Safety Review of Sibutramine (Meridia)

The FDA has announced an ongoing safety review of sibutramine (marketed as Meridia), a medicine used in the management of obesity. Early results from a recent study suggest 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).

The study, named the Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT), began in 2002. Patients included in the study were 55 years of age or older, overweight or obese, and had a history of heart disease or type 2 diabetes plus one additional cardiovascular risk factor. The early study results show 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 and suggests that sibutramine is associated with an increased cardiovascular risk in the study population.

The analysis of these results is ongoing and the FDA is making no conclusions about these early findings at this time. The FDA will communicate its findings to the public as soon as this review is complete.

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Source: FDA
Publication Date: 2009-11-23
Last Updated: 2009-12-04

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