Health Canada to boost warnings on ADHD drugs

Health Canada will add tougher warnings to the labels of Ritalin, Adderall, Concerta and similar drugs that treat attention deficit hyperactivity disorder, CBC News has learned.

Two million prescriptions for the stimulants, which increase blood pressure and speed up the pulse, were written in Canada in 2005. Use of the drugs is increasing.

Health Canada plans to add tougher warnings to the stimulants in April that caution people with a family history of heart problems, patients taking another stimulant and those who engage in strenuous physical activity.

The U.S. Food and Drug Administration (FDA) is also considering adding its strongest possible warning to the medications.

The strengthened warnings come after regulators received reports of 25 sudden deaths in American youngsters, as well as cases of heart attacks, strokes and psychosis among children and adults on the drugs.

'I want the physician's hand to tremble a little bit'

The chances of the drugs causing sudden death is rare, about one in 100,000 for children, said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic in Ohio and a consultant on an FDA advisory panel that recommended the warning.

Families and doctors need to be alerted to the risks, Nissen said.

"I want the physician's hand to tremble a little bit before they write the prescription for the drug."

Benefits often outweigh risks, ADHD expert says

Aside from Health Canada's stronger warnings, the department also cautions people with any heart risk factors to be screened before taking the drug.

But Dr. Margaret Weiss, head of British Columbia's ADHD program, says doctors already check for potential heart problems by requesting a complete physical exam and cardiac history before prescribing the drugs.

She said ADHD tends to be undertreated, and pointed out that the drugs have been used safely to treat the illness in millions of people.

"You're looking at the risk of a potential adverse event against the known risk from a very severe disorder," Weiss said.

• FROM FEB. 10, 2005: Health Canada withdraws ADHD drug

Nissen agreed. He is also calling for a patient guide that spells out the risks.

'It's definitely been a beneficial medicine for us'

Sandra LeBlanc, who has two sons taking Ritalin for ADHD, said yearly physical exams over more than a decade haven't showed any ill effects.

"It's definitely been a beneficial medicine for us," said LeBlanc, whose family lives in Charlottetown. "It's really improved the family life."

Regulators continue to look for possible side-effects from the drugs, including psychiatric problems.