TORONTO - Health Canada has waded into the controversy over the diabetes medication rosiglitazone, which is sold under the brand name Avandia.
The national drug regulator said Thursday it is watching the unfolding scientific debate over the safety profile of the drug, but has no new recommendations about its use at this point.
"The benefits of rosiglitazone are still considered to outweigh the risks when used as directed in the Canadian Product Monographs," the department said in a release that noted Health Canada recommends a more restrictive use of the drug than the U.S. drug regulator does.
Next week an expert panel convened by the U.S. Food and Drug Administration will look at the accumulated scientific evidence on the drug and determine whether Avandia should remain on the U.S. market. Health Canada said it would monitor hearings.
A critic of the drug said Health Canada should act now.
"I think they should be re-examining it," said Dr. David Juurlink of Toronto's Sunnybrook Health Sciences Centre.
Juurlink, who is a drug safety researcher and a specialist in internal medicine, published a study last summer that found people who took Avandia had a higher risk of serious heart disease events like heart failure, strokes and even death.
His is one of a number of studies that have suggested the drug is less safe than a sister medication, pioglitazone or Actos.
In May, Juurlink and the U.S. advocacy group Public Citizen called on the FDA to pull the plug on a large international trial comparing Actos and Avandia, saying it's unethical to continue it given the safety concerns about Avandia.
The drug's manufacturer, GlaxoSmithKline, insists a number of studies don't show an increased cardiovascular risk from using the medication.
Juurlink said Health Canada shouldn't wait for the outcome of the FDA panel to act.
"It will be curious if the FDA recommends removal of the drug from market and cessation of the TIDE trial to see if that is finally what it takes to get Health Canada to do the same," he said, adding that would be "optically quite bad" for Health Canada.
"They're a wise group of people, they've followed this issue for a long time and they should be able to act independently of the FDA."
