Subject: FDA MedWatch: Adderall XR (amphetamine) sales suspended in Canada due to reports of sudden deaths in pediatric patients
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA issued a Public Health Advisory to notify healthcare professionals that Health Canada, the Canadian drug regulatory agency, has suspended the sale of Adderall XR in the Canadian market. Adderall XR is a controlled release amphetamine used to treat patients with Attention Deficit Hyperactivity Disorder (ADHD). The Canadian action was based on U.S. post-marketing reports of sudden deaths in pediatric patients. FDA is continuing to evaluate these and other post-marketing reports of serious adverse events in children, adolescents, and adults being treated with Adderall and related products. Adderall XR is approved in the United States for the treatment of adults and pediatric patients 6-12 years old with ADHD, and Adderall, the immediate release formulation of the drug, is approved for pediatric patients with ADHD.
Read the complete MedWatch 2005 Safety Summary, including links to the Public Health Advisory, FDA Statement and other supporting information for healthcare professionals and patients, at:
http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Adderall
