Health Canada Advisory About Meridia In 2002 Follows Sales Suspension In Italy

Health Canada Investigates Safety Of Meridia (Sibutramine) With Focus On Heart-Related Side Effects

Following the Italian Health Ministry's suspension of the sale of diet drugs containing sibutramine in early March 2002, Health Canada issued an advisory on March 27, 2002 stating that it too is conducting a safety review of Meridia in Canada. Citing concerns for 28 reported adverse reactions associated with the use of sibutramine in Canada from December 28, 2000 to February 28, 2002, Health Canada is collaborating with foreign regulatory agencies in reviewing the safety of sibutramine.

Until the results of the review are made public, Health Canada is advising patients currently taking sibutramine to consult with their treating physician if they encounter any of the known adverse reactions, including cardiovascular reactions such as increased blood pressure, chest pain, stroke, as well as vision disturbances such as eye pain and eye hemorrhage.

Drugs containing sibutramine were approved for sale in Canada on December 28, 2000 under the trade name Meridia. No deaths have been associated with the use of Meridia in Canada, but the Italian Health Ministry has reported 50 adverse reactions and 2 deaths resulting from the use of sibutramine.

Adverse reactions to Meridia reported in Italy included tachycardia (increased heart rate), hypertension (increased blood pressure), arrhythmia (irregular heart rate), and cardiac arrest. Sibutramine is sold under the trade name Reductil in Italy. The matter has been referred to the European Medicines Evaluation Agency Secretariat for further evaluation.

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