FDA ALERT [8/2005] Health Canada Announces Return of Adderall to the Canadian Market.

Adderall will return to the Canadian market for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) (see alert of 2/09/05 below). The Canadian Product Monograph will be revised to include warnings about the misuse of Adderall and that Adderall generally should not be used in patients with structural cardiac abnormalities.

FDA ALERT [2/2005] Health Canada Suspends Marketing of Adderall

Health Canada has suspended marketing of Adderall XR products from the Canadian market due to concern about reports of sudden unexplained death (SUD) in children taking Adderall and Adderall XR.  SUD has been associated with amphetamine abuse and reported in children with underlying cardiac abnormalities taking recommended doses of amphetamines, including Adderall and Adderall XR.  In addition, a very small number of cases of SUD have been reported in children without structural cardiac abnormalities taking Adderall.  At this time, FDA cannot conclude that recommended doses of Adderall can cause SUD, but is continuing to carefully evaluate these data.

This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.