Advisory

2003-07
February 28, 2003
For immediate release

Health Canada reports back to public on safety profile of MERIDIA® (sibutramine)

OTTAWA - Health Canada is updating the public on safety information regarding sibutramine, a prescription drug sold as MERIDIA® in Canada. Health Canada has completed this review and has concluded that MERIDIA® (sibutramine) continues to meet the requirements for sale in Canada.

MERIDIA® (sibutramine) received Health Canada's approval for sale on December 28, 2000, for the treatment of obesity.

On March 27, 2002, Health Canada issued a public health advisory informing Canadians that it was conducting a review of the safety profile of the marketed drug in light of international regulatory action and adverse reactions reported in Canada and elsewhere. Last year's advisory explained that Italian authorities had temporarily suspended market authorisation of all drugs containing sibutramine in that country, primarily because of concerns regarding cardiovascular events and two deaths. The Committee for Proprietary Medicinal Products (CPMP) in Europe reassessed sibutramine in June 2002 and concluded that the benefit/risk balance of sibutramine-containing products was favourable. The Italian Ministry of Health revoked the temporary suspension of sibutramine on August 28, 2002, thus reinstating marketing approval in Italy.

There were 53 reports of adverse reactions associated with the use of MERIDIA® (sibutramine) reported to Health Canada from March 1, 2002 and November 13, 2002. No deaths have been reported. These reports are consistent with the known adverse reactions of MERIDIA® (sibutramine), which can include an increase in blood pressure and heart rate, and disturbances of the visual system such as eye pain and eye hemorrhage. Patients should not take MERIDIA® (sibutramine) while taking medications that can affect the level of serotonin in the brain, such as antidepressants. Patients should be monitored by their physicians while using MERIDIA® (sibutramine).

Health Canada continues to monitor the adverse event profile of MERIDIA® (sibutramine) . Consumers may report adverse drug reactions toll-free to Health Canada by telephone (866 234-2345) or fax (866 678-6789).

Media Inquiries:
Tara Madigan
Health Canada
(613) 946-4250

Public Inquiries:
(613) 957-2991
Health Canada