Health Canada Advisory

Health Canada Updates Safety Profile of Meridia (sibutramine)

Health Canada has completed its review of the safety profile of sibutramine, marketed as Meridia in Canada and the US, in February 2003. The review concludes Health Canada's March 2002 public health advisory, which was prompted by the suspension of Meridia sales in Italy by the Italian Health Ministry, also in 2002.

Italy's suspension of Meridia sales and Canada's safety review was prompted by reports of adverse reactions associated with the use of Meridia, including increased blood pressure and heart rate, possible visual disturbances, cardiovascular events, and even deaths.

Health Canada's most recent public advisory concludes that the benefit/risk assessment of Meridia is favorable and has approved the continued sale of Meridia in Canada. Italy, too, has revoked the temporary suspension of Meridia and reinstated market approval following a benefit/risk assessment of Meridia.

Health Canada provides Meridia information for the patient from the Product Monograph of Meridia at their website.