Adderall XR is a long-acting version of Adderall, a drug used to treat attention deficit hyperactivity disorder (ADHD). Earlier this year, the drug was taken off the market in Canada because of concerns over its safeness. Health Canada, their drug regulatory agency, took this action because 12 American children who took Adderall XR died between 1999 and 2003. The FDA didn't remove this drug from the U.S. market.
This past August, Health Canada reversed its decision, allowing the drug to be sold again. The regulators felt that, after a review by an expert panel in pediatric cardiology, pediatric development, and pharmacoepidemiology, the drug was safe and that its benefits outweighed its potential risks.
Health Canada recommended better educating doctors who prescribe the medicine and emphasizing the risks of sudden cardiac death in otherwise healthy children. In addition, the labeling now includes a warning that children with underlying heart disease may be at an increased risk of sudden cardiac death if given this medicine.
Family Practice News, 10/1/05
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