Drug Safety and Risk Management Advisory
Committee Meeting
February 9 and 10, 2006
TABLE OF CONTENTS
Tab 1: January
12, 2006 Cover Memorandum; Gerald J. Dal Pan, M.D., M.P.H.
Director, Office of Drug
Safety
Tab 4: Draft
Issues for Discussion-Day 1 (February 9, 2006)
o
Biederman J, Faraone
SV. Attention-Deficit Hyperactivity
Disorder. The Lancet, 2005; 366(Jul 16): 237-247
o
Liberthson RR. Sudden Death from Cardiac Causes in Children
and Young Adults. Current Concepts, 1996; 334(16): 1039-1044
o
Centers for
Disease Control and Prevention. Prevalence
of Diagnosis and Medication Treatment for Attention-Deficit/Hyperactivity
Disorder –
o
Adderall
o
Adderall XR
o
Concerta
o
Dexedrine
o
Ritalin LA
o
Ritalin SR
o
Focalin
o
Focalin XR
o
Metadate CD
o
Methylin
o
Strattera
o
Isotretinoin
Update: iPLEDGE
o
Isotretinoin
Teratogenicity Risk Management Program