Oct 11 2010
Abbott will voluntarily withdraw sibutramine from the Canadian market after discussion with Health Canada. Sibutramine is marketed by Abbott in Canada as Meridia.
It is recommended that patients taking Meridia make an appointment with their doctor at the next convenient time to discuss alternatives for losing weight. Patients who wish to stop treatment before seeing their doctor can do so at any time. Patient and physician questions can be answered through the toll-free service number established by Abbott in Canada: 1-800-562-2226 or 514-832-7333 or by visiting www.abbott.ca.
Health Canada's recommendation was based on a review of results from the SCOUT study (Sibutramine Cardiovascular OUTcome Trial), which became available in November 2009. The approximately 10,000 patient, six-year SCOUT study was requested by European regulatory authorities as a post-marketing commitment to evaluate cardiovascular safety in high-risk patients. The majority of the patients in the SCOUT study had underlying cardiovascular disease and were ineligible to receive sibutramine under the current labeling and prescribing information.
Abbott's evaluation of the SCOUT study does not change its assessment that sibutramine has a positive benefit/risk profile when used appropriately in the approved patient population.
Sibutramine is approved in Canada for weight loss in patients who are obese, have no previous history of cardiovascular disease and have been unable to lose weight through diet and exercise.
Source: ABBOTT
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