FDA ALERT [2/9/2005] Sudden Deaths in Children

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[sSRI-Research] FDA ALERT [2/9/2005] Sudden Deaths in Children

 

http://www.fda.gov/cder/drug/infopage/adderall/default.htm

 

 

 

 

Adderall and Adderall XR (amphetamines) Information

 

 

FDA ALERT [2/9/2005]

 

Sudden Deaths in Children

 

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.

 

a.. Patient Information Sheet [PDF] or

b.. Healthcare Professional Information

a.. Healthcare Professional Sheet [PDF] or [html]

b.. Prescribing Information (Adderall Label)

Other Information

 

a.. Public Health Advisory for Adderall and Adderall XR

 

b.. FDA Statement on Adderall

 

c.. Regulatory History of Adderall from Drugs@FDA

 

Report Adverse Events to MedWatch

 

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Date created: February 9, 2005