FDA Reports Apparent Excess of CV Events With Sibutramine in SCOUT

November 23, 2009

November 23, 2009 (Rockville, Maryland)— The FDA is alerting patients and providers about an apparent jump in cardiovascular events among patients taking sibutramine (Meridia, Abbott Laboratories) for weight loss in a preliminary analysis from a randomized placebo-controlled trial launched in 2002 [1]. The trial focused on a population with a high CV risk that includes many patients sibutramine's current labeling says should not receive the drug [2].

The appetite suppressant, a centrally acting serotonin-norepinephrine reuptake inhibitor, is marketed as Meridia in the US and Reductil in Europe, among other names.

The FDA describes the Sibutramine Cardiovascular Outcomes Trial (SCOUT), which enrolled >10 742 overweight or obese patients with diabetes or a history of coronary, peripheral vascular disease, or stroke, along with other CV risk factors, as "part of a postapproval commitment between the European Medicines Agency (EMEA) and the manufacturer."

An early analysis for the trial's primary end point, a composite of "heart attack, stroke, resuscitated cardiac arrest, or death," found the rate to be 11.4% for patients receiving sibutramine and 10% for those receiving placebo.

"This difference is higher than expected, suggesting that sibutramine is associated with an increased cardiovascular risk in the study population," according to the agency, which approved the drug in 1997. The "FDA is considering but has not reached a conclusion about whether this information warrants any regulatory action."

The 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. Additionally, healthcare professionals should continue to evaluate the benefits and risks of sibutramine, taking into account individual patient medical histories," the FDA states.


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