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Call for scrutiny of 'off-label' drugs

Six years ago, Ellyn Braun's doctor told her that the acne medication she was taking could double as birth control, even though Health Canada doesn't regulate it as a form of contraception.

The drug, Diane-35, is regulated for temporary acne treatment, but Braun's been using it on a permanent basis as a birth control pill, even though it has been linked to the deaths of nine Canadians since 2000.

That doesn't seem to faze Braun.

"I think there's a place for it, but you just have to be careful about it," says the 28-year-old medical student at McMaster University in Hamilton.

She's far from alone. "Off-label" prescriptions, using drugs to treat illnesses for which they haven't been approved by Health Canada, is a growing "social experiment" in Canada that demands more careful scrutiny, experts say.

Canada needs a national monitoring system to keep tabs on the practice, said Dr. Robyn Tamblyn, scientific director with the Canadian Institutes of Health Research and a researcher at McGill University in Montreal.

"Off-label use is a reality," Tamblyn said in an interview.

"It is occurring more and more often¦ and there's been very little research in this area because of this whole issue of not collecting information."

A study co-authored last year by Tamblyn found 11 per cent of prescriptions in Canada are off-label; in 79 per cent of those cases, there was no evidence to back up the doctor's decision.

The study found most of the drugs used for unregulated purposes were anticonvulsants, antipsychotics and antidepressants. As well, it found that if the drug was approved for three or four different uses by Heath Canada, it was less likely to be used off-label as opposed to drugs only approved for one or two uses.

The Canadian Press


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