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Comparison Between Original ODS and Current DNDP Analyses of Pediatric Suicidality Data Sets

September 13, 2004 Meeting of Psychopharmacological Drugs Advisory Committee and Pediatric Drugs Advisory Committee. Comparison Between Original ODS and Current DNDP Analyses of Pediatric Suicidality Data Sets Andrew D. Mosholder, M.D., M.P.H. Office of Drug Safety.

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Comparison Between Original ODS and Current DNDP Analyses of Pediatric Suicidality Data Sets

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  1. September 13, 2004 Meeting of Psychopharmacological Drugs Advisory Committee and Pediatric Drugs Advisory Committee Comparison Between Original ODS and Current DNDP Analyses of Pediatric Suicidality Data Sets Andrew D. Mosholder, M.D., M.P.H. Office of Drug Safety

  2. ODS Analysis of Suicidal Events in Pediatric Trials with Antidepressant Drugs • Same trials as DNDP analysis, except for TADS • Events determined from responses to July 2003 data requests • used sponsor-identified suicide related events that were also classified as serious • predated Columbia University reclassification

  3. Differences in Analytic Methods

  4. ODS Analysis: Overview of Data • Drug N = 2227, patient-years = 406.9 • no completed suicides • 74 sponsor-defined suicide related events, 54 serious • Pbo N = 1916, patient-years = 347.6 • no completed suicides • 34 sponsor-defined suicide related events, 24 serious

  5. ODS Analysis: Overview of Data, continued • Definition of “serious” adverse drug experiences (21CFR 312.32): • fatal • life-threatening • involve hospitalization • disabling • congenital defect • Sponsor determined whether an adverse event in a clinical trial was serious • ODS “serious suicide-related events” will be compared to Columbia University “definitive suicidal behavior/ideation”

  6. Comparison of Case Classifications • ODS Serious, suicide-related events n=78 • 61 were classified by Columbia Univ. as “definitive suicidal behavior/ideation” • 13 of the remaining 17 cases classified as self-injurious behavior with unknown intent • Columbia University “definitive suicidal behavior/ideation n=95 • 61 also were ODS serious, suicide-related events • 18 new cases • 16 sponsor-defined suicide-related events, but nonserious (thus not included in ODS analysis)

  7. Additional Topics(reference: March 2004 consult memo) Incidence rate difference analysis Comparison to adult data for paroxetine Discontinuation events

  8. Possible Role of Drug Discontinuation?

  9. Conclusion Both the original ODS analysis, and the current DNDP analysis using the Columbia University reclassification of cases, indicate an association of suicidality with antidepressant drug treatment in short-term, placebo-controlled pediatric trials

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