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WASHINGTON, Jan. 21 (UPI) -- U.S. government officials said Thursday the manufacturer of the weight-loss drug sibutramine, or Meridia, will issue a tougher warning about the drug.
Officials at the Food and Drug Administration said Abbott Laboratories agreed to add new information to the existing warning, to the effect that sibutramine may increase the risk of heart attack and stroke, MedPage reported.
Specifically, the warning is to include patients with a history of:
-- Coronary artery disease, heart attack, angina.
-- Stroke or transient ischemic attack.
-- Arrhythmia.
-- Congestive heart failure.
-- Peripheral arterial disease.
-- Uncontrolled hypertension more than 145/90 mmHg.
Healthcare professionals should monitor patients for increase in blood pressure and heart rate and the drug should be stopped if an increase is observed in either, FDA officials said.
The European Medicines Agency said Thursday it completed a safety review and sibutramine should stop being marketed in Europe because "the risks of these medicines are greater than their benefits."
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