warnings, side effects
Adderall and Adderall XR (amphetamines) Information
FDA ALERT [08/2005] Health Canada Announces Return of Adderall to the
Adderall will return to the Canadian market for the treatment of Attention
Deficit Hyperactivity Disorder (ADHD) (see alert of 02/09/05 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 [02/2005] 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 FDAÂ’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.
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