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SILVER SPRING, Md. Clinical trial data indicating an increased risk of heart attack and stroke has led to the removal from the market of an obesity drug made by Abbott, the Food and Drug Administration said Friday.
The FDA said the drug maker voluntarily withdrew the drug Meridia (sibutramine) following a required post-marketing trial showing that the drug increased by 16% the risk of nonfatal heart attacks and strokes, the need for resuscitation after the heart stopped and death.
“Meridia’s continued availability is not justified when you compare the very modest weight loss that people achive on this drug to their risk of heart attack or stroke,” FDA office of new drugs director John Jenkins said. “Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their healthcare provider about alternative weight loss and weight-loss maintenance programs.”
The FDA approved Meridia in 1997 for weight loss and maintenance of weight loss in obese people and some overweight people with other risks for heart disease, based on clinical trial data showing that people taking the drug lost at least 5% of their body weight compared with those taking placebo who relied on diet and exercise alone.