The weight loss drug Meridia is being pulled from drug stores in Canada and the United States by its maker over links to serious side-effects in some patients.Illinois-based pharmaceutical company Abbott Laboratories said Friday it was voluntarily withdrawing sibutramine, which is also marketed in generic forms.
"Abbott believes sibutramine has a positive risk/benefit profile in the approved patient population, but will comply with the (U.S. health authority's) request," the company said in a statement.
The recalls come almost a year after studies showed the drug increases the risk of heart attacks and strokes in patients with a history of heart disease.
European regulators banned all anti-obesity drugs containing sibutramine in January.
The drug, authorized for sale in 2000, has not been recommended for use in patients with existing heart disease, and Health Canada has also warned of the risks associated with the drug, Health Canada said.
"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," it said in a statement.
"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."
A U.S. Food and Drug Administration panel of 16 experts was split Wednesday on whether to enhance labelling and risk management activities or to withdraw the drug completely over the studies' findings.
The studies behind the recall involved almost 11,000 older, overweight or obese adults with Type 2 diabetes or heart disease or both who were randomly chosen to take either Meridia or a placebo and followed for about 3.4 years.
In the group taking Meridia, 11.4 per cent had a heart attack, stroke or died as the result of a heart problem, versus 10 per cent in the control group, a 16 per cent increase.
People taking Meridia also had a 28 per cent higher risk for non-fatal heart attack and a 36 per cent raised risk for non-fatal stroke, compared with those taking a placebo, the researchers found.
Patients are advised to stop using any form of sibutramine and talk to their doctors about alternatives.
Abbott is a broad-based health care company that develops and markets drugs, medical and diagnostic devices. The company employs nearly 90,000 people and markets its products in more than 130 countries.
Shares in the company were up 18 cents at US$52.76 in midday trading Friday on the New York Stock Exchange.