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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