Abbott also withdraws Meridia in Canada
Abbott Laboratories has voluntarily removed sibutramine (Meridia) off Canadian shelves after data from the SCOUT trial showed that the drug may have the potential to be linked with an increased risk of cardiovascular (CV) events in patients with heart problems.
Last week, Abbott hesitantly removed sibutramine, a drug used to curb obesity, from the U.S. shelves; however the company continued to urge that the drug had “a positive risk/benefit profile” in certain approved patient populations.
The drug was first authorized for sale in December 2000; however, it is not recommended for patients with existing incidence of CV disease. Health Canada has reportedly warned physicians about the importance of prescribing the drug as directed in the Canadian Product Monograph.
“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 CV disease may not have symptoms,” Health Canada wrote. “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.”
According to Health Canada, sibutramine is also approved in a generic form in Canada and said that it will take the appropriate measures for all of the sibutramine-containing products on the market.
Last week, Abbott hesitantly removed sibutramine, a drug used to curb obesity, from the U.S. shelves; however the company continued to urge that the drug had “a positive risk/benefit profile” in certain approved patient populations.
The drug was first authorized for sale in December 2000; however, it is not recommended for patients with existing incidence of CV disease. Health Canada has reportedly warned physicians about the importance of prescribing the drug as directed in the Canadian Product Monograph.
“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 CV disease may not have symptoms,” Health Canada wrote. “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.”
According to Health Canada, sibutramine is also approved in a generic form in Canada and said that it will take the appropriate measures for all of the sibutramine-containing products on the market.