The U.S. Food and Drug Administration has begun an expedited safety review of sibutramine based on a recent study showing that some patients have a higher rate of heart attacks, strokes and other cardiovascular events after taking the weight loss drug. Abbott Laboratories markets sibutramine as the popular weight loss drug Meridia.
Although the FDA has not made any conclusions, it is studying the initial data from a six-year study referred to a s the SCOUT study which examined the effects of the drug on overweight or obese subjects at risk of a cardiovascular event.
The SCOUT study results demonstrate the need for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke to avoid using sibutramine or Meridia.
The SCOUT data looked at roughly 10,000 patients who were at least 55, overweight or obese and had a history or heart disease or type 2 diabetes as well as at least one other cardiovascular risk factor. The study did not include those who had recently suffered a heart attack or stroke. The study was designed to demonstrate that weight loss achieved through sibutramine and "standard care" lowered the number of cardiovascular events more effectively than weight loss reached through a placebo and standard care.
The FDA said it "understands the serious nature of the preliminary data" and vowed to share its conclusions with the public as soon as it finishes its expedited safety review.