Health Canada, the Canadian drug regulatory agency, suspended the sale of Adderall XR, the controlled-release amphetamine used to treat patients with attention deficit hyperactivity disorder (ADHD). The agency took the action based on United States postmarketing reports of sudden, unexplained deaths in pediatric patients. The FDA is evaluating these and other postmarketing reports of serious adverse events in children, adolescents, and adults being treated with Adderall and related products. In the United States, Adderall XR is approved for the treatment of patients 6 to 12 years of age with ADHD. Adderall, the immediate-release form of the drug, is approved for pediatric patients with ADHD.

The FDA notes that sudden unexplained death in children taking Adderall and Adderall XR has been associated with amphetamine abuse and reported in children with underlying cardiac abnormalities taking recommended doses of amphetamines, including Adderall and Adderall XR. A very small number of cases of sudden unexplained death have been reported in children without structural cardiac abnormalities taking Adderall.

At this time, the FDA cannot conclude that recommended doses of Adderall can cause sudden unexplained death, but is continuing to carefully evaluate the data.