Drug Safety and Risk Management Advisory Committee Meeting

February 9 and 10, 2006




Tab 1:        January 12, 2006 Cover Memorandum; Gerald J. Dal Pan, M.D., M.P.H.

                  Director, Office of Drug Safety


Tab 2:        Federal Register Notice, “Drug Safety and Risk Management Advisory Committee Meeting, Notice of Meeting,” January, 2006


Tab 3:        Draft Meeting Agenda


Tab 4:        Draft Issues for Discussion-Day 1 (February 9, 2006)


Tab 5:        January 12, 2006; Note to DSaRM Members; Review of AERS data for marketed safety experience during stimulant therapy: death, sudden death, cardiovascular SAEs (including stroke) – Consult


Tab 6:        Bibliography

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 – United States, 2003. MMWR,  2005; 54(34): 842-847


Tab 7:   Drug Product Labels

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


Tab 8:  Center for Drug Evaluation and Research: Manual of Policies and Procedures 4151-3; Drug Oversight Board, May 4, 2005


Tab 9:  April 6, 2005; Memorandum and Attachments; John K. Jenkins, M.D. and Paul J. Seligman, M.D Analysis and Recommendations for Agency Action Regarding Non-steroidal Anti-Inflammatory Drugs and Cardiovascular Risk


Tab 10:  Isotretinoin Update

o       Isotretinoin Update: iPLEDGE

o       Isotretinoin Teratogenicity Risk Management Program