Canada, Europe. Health Canada has launched a safety review of the prescription drug sibutramine (Meridia) in view of the accumulating adverse reaction reports with the drug in Canada and elsewhere in the world. Sibutramine was approved for sale in Canada in December 2000 as an obesity treatment to be used in combination with diet and exercise. Although no deaths have been reported, there have been reports of adverse reactions associated with the use of sibutramine in Canada from December 2000 to February 2002. These reports are consistent with 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 haemorrhage. Health Canada is contacting and collaborating with regulatory agencies in other countries in reviewing the safety of sibutramine and will communicate the results to the public and take further action if required. The market authorisation for all drugs containing sibutramine has been suspended in Italy since March 6, 2002 following 50 adverse reaction reports including seven serious cases and two deaths. Arrhythmia and cardiac arrest were reported to be associated with the two deaths. Several other European countries such as France, Germany, England, the Netherlands, Denmark, Portugal, Sweden, Finland and Spain have issued statements informing the public of this market suspension in Italy. France, Germany and England are conducting additional reviews but have not withdrawn the drug.
Health Canada Warnings/Advisories, 27 March 2002.
Available from URL: http://www.hc-sc.gc.ca