FDA Advisory on Adderall (May 2005)
FDA recently issued a Public Health Advisory describing reports of sudden unexplained death in children taking Adderall and Adderall XR, which are used to treat ADHD.
Sudden death has been reported in children with underlying cardiac abnormalities who are taking recommended doses of amphetamines, including Adderall and Adderall XR. A very small number of cases of sudden death have been reported in children without cardiac abnormalities taking Adderall.
At this time, it doesn't appear that the number of sudden deaths in children taking Adderall is greater than the number that would be expected in this population without treatment. But it's possible that patients with underlying heart defects might be especially at risk, and so the advisory reemphasizes the warning in the product labeling that these patients should ordinarily not be treated with Adderall products.