HEALTH Canada says the deaths of several Canadians could be linked to the popular Type 2 diabetes drug Avandia, the Free Press has learned.
Last week, a report in the New England Journal of Medicine linked Avandia to a greater chance of heart attack and possibly death.
Initially, Health Canada told the media that 28 Canadians who were taking Avandia suffered heart attacks since 2000. They didn't say if any of the heart attacks were fatal.
But after the Free Press looked into Health Canada's adverse-reaction database, spokeswoman Renee Bergeron confirmed 19 people have died from heart attacks or heart failure while taking Avandia.
Health Canada said the drug may have caused a third of the deaths.
In 12 cases there is not enough information to determine whether Avandia played a role in the death, and Avandia has been ruled out as a potential cause in one of the cases.
About 4,200 Manitobans had a prescription for Avandia last year.
"Our preliminary review indicates that there is a possible link between the drug and death in six cases," Bergeron said.
Drug-safety advocates like Colleen Fuller, chairwoman of Vancouver-based non-profit PharmaWatch, said the government should warn Canadians about the potential risks of Avandia and do a full risk assessment of the drug immediately.
She said the government is not doing enough followup after drugs are approved and is concerned Avandia could become the next recalled medication.
Popular painkiller Vioxx was pulled from the market in 2004, after it was found to increase the risk of heart attack.
"These drugs are coming onto the market and being heavily promoted before there is some understanding of what their impact is going to be," Fuller said.
"It just makes me very, very angry that the government is now dragging its feet when there are alarm bells going on with this particular drug and they're still not doing anything."
Avandia is manufactured by pharmaceutical giant GlaxoSmithKline and was approved for use by Health Canada in March 2000. It is marketed to lower blood sugar levels and help the body use its own natural insulin better.
But by late November 2001, the safety of Avandia was in question.
Health Canada released an advisory warning to Canadians on Nov. 30 that drugs like Avandia "can cause fluid retention that can progress to congestive heart failure."
Anyone who had acute heart failure, liver disease or shortness of breath, swelling, or fatigue was advised to consult their physician.
But earlier this week, Bergeron said the government has no plans to put out any public warnings or advisories about the medication or change its drug labels. Bergeron said that's because they don't know whether Avandia caused the adverse reactions.
"We are actively reviewing this information but can not yet comment on the Canadian experience with the drug," she said.
Derek Risbey, a pharmacist and adviser for the Canadian Diabetes Association based in Winnipeg, said patients taking Avandia should not stop taking their medication until they talk to their doctor.
He said he's received several questions about Avandia from concerned patients in Winnipeg over the last week, but is telling people not to panic.
Until there is further research, Risbey said there is no way to tell whether the risks of Avandia for a few people outweigh the benefits.
"It's not an emergency, you don't have to rush down (to see your doctor)," he said.
jen.skerritt@freepress.mb.ca
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