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Yet the new warning from the FDA advises that the benefits of the medication fail to outweigh the enhanced risk of heart attack and stroke in sibutramine users. Patients with a history of heart attack, angina, heart failure, stroke, heart arrhythmia and peripheral artery disease are at particularly high risk.
The findings have provoked European medical agencies to pull the drug from its shelves and stop actively prescribing the medication. The FDA, however, will only require that Abott Laboratories - the manufacturer of the medication - place a stronger warning on its label.