US Pharm. 2010;35(12):100.Abbott Laboratories has agreed to voluntarily withdraw its obesity drug Meridia (sibutramine) from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke, the FDA announced. Meridia was approved by the FDA in November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. The approval was based on clinical data showing that more people receiving sibutramine lost at least 5% of their body weight than people on placebo who relied on diet and exercise alone.
“Meridia's continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke,” said John Jenkins, MD, director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research. “Physicians are advised to stop prescribing Meridia to their patients and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs,” said Jenkins.