OTTAWA – Health Canada is informing healthcare practitioners and Canadians that Abbott Laboratories is voluntarily withdrawing the prescription weight-loss drug sibutramine, which is marketed under the brand name Meridia®, from the Canadian market.
Abbott’s decision, in collaboration with Health Canada, comes in light of data from the Sibutramine Cardiovascular OUTcomes (SCOUT) trial, a large study that suggested an increased risk of serious cardiovascular events associated with sibutramine use in patients with heart problems. The purpose of the study was to determine a link between long-term sibutramine use and the risk of cardiovascular events in patients with pre-existing cardiovascular disease, or who were at risk of heart-related adverse events. Nearly 10,000 overweight and obese subjects aged 55 years and older were enrolled in the trial for up to six years.
It’s important to note that since sibutramine was first authorized for sale in December 2000, it has not been recommended for use in patients with existing cardiovascular disease. Health Canada has communicated in the past on the risk of cardiovascular events in patients with heart problems and on the importance of prescribing sibutramine as directed in the Canadian Product Monograph. Most recently, in October 2007, Health Canada published an article in the Canadian Adverse Reaction Newsletter on the subject.
Despite these previous risk mitigation measures, there continues to be concern of an increased risk of heart-related adverse events, particularly as people at risk of cardiovascular disease may not have symptoms. In light of this concern, and the accumulating scientific evidence on the safety and efficacy of Meridia®, it has been determined that the benefits no longer outweigh the risks for this drug.
Sibutramine is also authorized in Canada in generic forms. Health Canada will take appropriate action with respect to all sibutramine-containing products on the market.
Patients currently taking Meridia® (sibutramine) should contact their healthcare practitioner regarding potential alternatives. Pharmacists and patients with questions regarding their current stock of Meridia® should contact Abbott Laboratories directly at 1-800-567-2226.