Patients in Canada with attention-deficit hyperactivity disorder are now able to obtain Adderall XR.
Sales of the drug, distributed by Shire Pharmaceuticals Group PLC, had been suspended earlier this year in Canada after the release of postmarketing reports of sudden death in 12 children in the United States who had taken the drug between 1999 and 2003.
At Shire's request, Health Canada, that country's drug regulatory agency, convened the New Drug Committee, a three-member panel of experts in pediatric cardiology, pediatric development, and pharmacoepidemiology, to review the suspension of the drug. The committee's recommendation to reinstate Adderall XR, which came in late August, hinged on the adoption of revisions to the Canadian version of the product monograph and to the patient leaflet.
The committee also recommended a Dear Healthcare Professional letter, as well as continuing medical education about sudden death in otherwise healthy children. The product label had been changed in August 2004 to include a warning that patients with underlying heart disease might be at increased risk for sudden death.