Adderall (amphetamines)
warnings, side effects
Adderall and Adderall XR (amphetamines) Information

FDA ALERT [08/2005] 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
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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