Advisory
2002-21
March 27, 2002
Health Canada investigates safety of MERIDIA® (Sibutramine)
OTTAWA - In light of recent international regulatory action and numerous adverse reactions reported in Canada and elsewhere, Health Canada is conducting a safety review of the prescription drug MERIDIA® (sibutramine). Sibutramine was approved for sale in Canada on December 28, 2000, as a prescription drug for the treatment of obesity, under the trade name MERIDIA®. Sibutramine is approved as an obesity treatment to be used in combination with diet and exercise. Patients who are currently taking sibutramine are advised to consult with their treating physician if they have any questions or concerns regarding the treatment of their condition with this drug. Patients should be monitored by their physician while they are taking sibutramine.
Although no deaths have been reported, there have been 28 reported adverse reactions associated with the use of sibutramine in Canada from December 28, 2000 to February 28, 2002. These reports are consistent with the known adverse reactions of sibutramine, which include cardiovascular reactions such as increased blood pressure, chest pain, stroke, as well as disturbances of vision such as eye pain and eye hemorrhage. Health Canada is contacting and collaborating with foreign regulatory agencies in reviewing the safety of sibutramine. Health Canada will communicate the results to the public and take further action if required.
Internationally, Italian authorities temporarily suspended market authorisation of all drugs containing sibutramine in that country on March 6, 2002, and have referred the matter to the European Medicines Evaluation Agency Secretariat for a comprehensive assessment of the risk/benefit profile of sibutramine. Sibutramine was approved for sale in Italy in April 2001, and since that time 50 adverse reactions have been reported to the Italian authorities. Seven of these reactions are considered to be serious, and 2 deaths have been reported. The most commonly reported reactions in Italy were tachycardia (increased heart rate) and hypertension (increased blood pressure); arrhythmia (irregular heart rate) and cardiac arrest were reported to be associated with the 2 deaths.
Several European countries such as France, Germany, England, the Netherlands, Denmark, Portugal, Sweden, Finland and Spain have issued statements informing the public of the market suspension of sibutramine in Italy. France, Germany and England have announced that they are conducting reviews of sibutramine but have not withdrawn the drug from the market.
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Media Inquiries:
Ryan Baker
Health Canada
(613) 941-8189
Public Inquiries:
(613) 957-2991
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