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All Marketed Sibutramine Drugs Voluntarily Withdrawn in Canada

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Ottawa, ONFurther to Health Canada's October 8, 2010, communication on the voluntary recall by Abbott Laboratories of Meridia (the brand name for the weight-loss drug sibutramine), Health Canada is updating healthcare practitioners and Canadians with respect to the two generic forms of sibutramine drugs authorized in Canada: Apo-sibutramine and Novo-sibutramine.

Apotex Inc., the manufacturer of Apo-sibutramine, has agreed to voluntarily withdraw this drug from the Canadian market. Teva Canada Ltd., the manufacturer of Novo-sibutramine, has confirmed to Health Canada that it has not marketed this drug in Canada, i.e., Novo-sibutramine is not available for sale on the Canadian market.

These withdrawals are based on data from the Sibutramine Cardiovascular OUTcomes (SCOUT) trial, a large study that suggested an increased risk of serious cardiovascular events associated with sibutramine use in patients with heart problems. The purpose of the study was to determine a link between long-term sibutramine use and the risk of cardiovascular events in patients with pre-existing cardiovascular disease, or who were at risk of heart-related adverse events. Nearly 10,000 overweight and obese subjects aged 55 years and older were enrolled in the trial for up to six years.



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