Canada weighs tighter rules on Avandia diabetes drug

Popular diabetes drug Avandia is being pulled off the market in Europe and will face tighter restrictions in the U.S. because of fears patients who take it face an increased risk of heart attacks, stroke and other cardiovascular problems.

The decision is a blow to GlaxoSmithKline Inc., the company that sells Avandia, the brand name of the diabetes drug rosiglitazone.

It also raises questions about further regulatory restrictions in Canada. Health Canada said in 2007 that, because of the potential for cardiovascular problems, Avandia shouldn't be taken on its own unless patients can't tolerate other diabetes drugs. Similar restrictions were announced Thursday by the U.S. Food and Drug Administration.

But the European Medicines Agency, which evaluates drugs in the European Union, recommended suspending Avandia's market authorizations and said it would no longer be available there in the next few months.

In July, Health Canada said it was continuing to review the safety of Avandia and that it was closely monitoring developments in the U.S. The department issued a public advisory in July saying it would take "the appropriate regulatory action necessary" pending the outcome of safety investigations in other countries.

Department officials said they are considering further action following Thursday's announcements.

GSK said in a statement that Health Canada is looking to add a "serious warning and precautions" box to Avandia medications sold here, and that the company has suspended marketing of the drug.

Avandia was introduced to the market about a decade ago and was seen as a major breakthrough in helping people with Type 2 diabetes lower their blood sugar.

But several studies published in recent years linked Avandia to an increased risk of cardiovascular problems. Studies have also suggested that Avandia doesn't perform any better than a rival drug, Actos, which is not associated with the same level of safety risks.

In Canada, more than one million prescriptions for Avandia were dispensed in 2005, according to IMS Health Canada, a company that monitors the pharmaceutical market. By 2009, that number had slipped to just under 580,000, reflecting negative news reports about the drug.

John Abbott, CEO of the Health Council of Canada, said health officials here should pay close attention to decisions being made on Avandia. But the problems with the drug also signal the need to change the way Canada monitors drug safety.

"We need to have more active surveillance systems put in place," Mr. Abbott said. "Our system needs improvement."