A drug to treat attention deficit disorder is being pulled off the market by Canadian regulators, who are reviewing the safety of similar drugs such as Ritalin.

The drug, called Adderall XR, has been linked to 20 sudden deaths, including 14 among children, as well as a dozen strokes, Health Canada said. Children suffered two of the strokes.

None of the deaths happened in Canada, and none were the result of abuse, misuse or overdose of the amphetamine.




The once-a-day Adderall XR or extended release formula was approved for use in Canada in January 2004. The capsules can be opened to sprinkle the drug on food.

Patients who were prescribed the drug or their parents should consult their doctor immediately and return any capsules to a pharmacy, Health Canada advises on its website.

Health Canada is asking makers of related stimulants for ADHD, including Ritalin, to provide an update of worldwide safety data for the department to review. The department expects to complete the review of ADHD drugs in a month or more.

Dr. Umesh Jain
Dr. Umesh Jain

Ritalin is used by tens of thousands of Canadian children with ADHD and has been prescribed for decades. The three other ADHD drugs under review are Concerta, Dexadrine and Attenade.

"Obviously this is going to affect how everybody views all stimulants until we get better data," said Dr. Wendy Roberts, a developmental pediatrician at Toronto's Hospital for Sick Children.

Shire Pharmaceuticals Group PLC makes Adderall XR, as well as an immediate-release version of the drug that is sold in the U.S. but isn't approved in Canada.

Safety review

Shire said it is complying with Health Canada's order but the company stands behind the safety of the product, which remains on the market in the U.S.

When the U.S. Food and Drug Administration looked at Shire's safety data, the regulator opted to put a warning label on the drug, saying it should not be used by patients whose hearts have structural abnormalities.

On the other hand, Health Canada concluded a warning label is inadequate, given the deaths were sudden and the cause unknown, said Dr. Robert Peterson, director general of the department's therapeutic products directorate.

Some doctors who treat ADHD say the directorate acted prematurely in failing to consult with physicians before pulling the drug.

"We have a crisis on our hands, with frantic patients and doctors scrambling to decide what to do with this decision," said Dr. Umesh Jain, a child psychiatrist at the Centre for Addiction and Mental Health in Toronto.

About 11,000 Canadians take Adderall XR, mostly children. The drug accounts for $10 million in Canadian sales for Shire.