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The Globe and Mail

It’s time to ensure medications are safe for children in Canada

Last week, Health Canada announced that medications used to treat attention deficit hyperactivity disorder will now have to carry a warning, alerting consumers to the fact they may lead to an increased suicide risk.

Alarming, to say the least, considering that this class of drugs – which includes Ritalin, Adderall and Biphentin – are taken widely by young people across the country. (Statistics Canada reports that from 2007 to 2011, about 6 per cent of males and 2.5 per cent of females between the ages of 6 and 14 took medications to treat ADHD.)

But the announcement is also alarming for another reason: It's one of the few times we hear from our federal health regulator about the safety of medications given to children.

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You might be surprised to learn that Canada does not require drug manufacturers to test prescription medications on children for safety or efficacy. For the most part, drugs are prescribed to children "off label," meaning they weren't specifically approved for that purpose.

This is a dangerous gap that must be closed.

Children are not small adults. Their bodies, and brains, are developing and they often don't react to drugs the same way adults do. It's highly possible that medications designed for adults will have unexpected side effects when taken by a child. And because Health Canada doesn't require companies to provide safety data, it's possible that emerging information about risks linked to a certain drug won't quickly come to light in Canada.

"It's a travesty that we've gone on for years with this double standard," said Dr. Stuart MacLeod, professor of pediatrics at the University of British Columbia. "There's one standard that applies to drugs going to be given to adults and another for children."

MacLeod recently led an expert panel convened by the Council of Canadian Academies to study this issue. The group's report, released last September, concluded that medications should be studied in children and formulated specifically for them to ensure they work and are safe. The report also notes that in the United States and European Union, studying medications in children is required – so it should be here, too.

Of course, many young people do take medications regularly and don't run into trouble. That can be attributed to careful prescribing as much as anything else. But for plenty of other children and adolescents, off-label prescribing of medications designed for adults has come at a heavy price. For instance, a growing number of young people are being prescribed powerful antipsychotic drugs that are typically used to treat severe mental illness. Among children and teens, however, those drugs are being used to treat anxiety, behaviour problems, depression, autism and insomnia. The risks include muscle tremors and abnormal excessive weight gain.

Children have medical conditions that require pharmaceutical treatment. And, like adults, they deserve to be given drugs that have been thoroughly tested and formulated specifically for them.

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One of the long-standing arguments that stood in the way of more drug research among young people is that they are vulnerable and doing those kinds of studies is too much of an ethical compromise. But as the Council of Canadian Academies points out in its report, the best way to protect children is not to shield them, but to include them in medical research that could lead to dramatic improvements in drug efficiency, effectiveness and safety.

There is some hope on the horizon. The passage of Vanessa's Law last year will allow the federal health minister to compel companies to provide safety data or other information about prescription drugs. That could help fill the void of information that currently exists in terms of medications given to children, although whether it will make a difference remains to be seen.

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