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Professor Joel Lexchin: Health Canada should beef up drug-monitoring system

Health Canada did not pull a pain drug off the market until US officials made the decision to recall it, a move sparking criticism of the government’s ability to act independently to protect the safety of Canadians from potentially dangerous medications, reported The Globe and Mail Dec. 3:

Health Canada and Paladin Labs Inc. announced a recall Wednesday of Darvon-N, the brand name of dextropropoxyphene, also known as propoxyphene, after new research showed the drug is linked to serious abnormal heart rhythms. The announcement came less than two weeks after the US Food and Drug Administration decided the drug should be removed from the market.

But widespread safety concerns about the drug have actually been around for decades, and prompted Britain and the European Union to ban Darvon-N amid fears it was linked to suicide and accidental overdose.

Joel Lexchin, a professor in York’s School of Health Policy & Management, said Health Canada should have taken an active role with respect to Darvon-N, as well as other drugs. The department’s follow-the-leader behaviour exposes major shortcomings and weaknesses in its drug monitoring capabilities, he said.

“This drug should have been off the market 30 years ago,” Lexchin said in an interview Thursday. “Unfortunately, it took this long to get it off the market.”

Health Canada should beef up its system for monitoring the safety of drugs as well as tracking the number of patients who experience serious side effects, he said.

Lexchin is a co-author of Keeping an Eye on Prescription Drugs, Keeping Canadians Safe, which calls for sweeping improvements to drug safety in Canada.

Posted by Elizabeth Monier-Williams, research communications officer, with files courtesy of YFile– York University’s daily e-bulletin.