Adderall XR
Adderall XR is approved in the United States for the treatment of
adults and pediatric patients 6 years of age and older with Attention
Deficit Hyperactivity Disorder (ADHD). Canada has suspended the sale of
Adderall XR in the Canadian market. The Canadian action was based on
reports of sudden deaths in pediatric patients using the drug. The Food
and Drug Administration (FDA) is aware of these and evaluated the risk
of sudden death with Adderall XR prior to approving the drug for adults
last year.
Of 12 total fatalities reported, five occurred in patients with
underlying structural heart defects which already increase the risk of
sudden death. The FDA is evaluating these and other reports of serious
adverse events in children, adolescents, and adults being treated with
Adderall XR, however it does not appear that the FDA will take any
regulatory action at this time.
The labeling for Adderall XR was changed in the United States in
August 2004 to include a warning that patients with the structural
heart defects might be at risk, and should ordinarily not be treated
with Adderall XR.