Feb/Mar 2004 Internal Suppressed FDA Memos

March 2004 Avigan Memo Re: Mosholder Report

Memo Page 1

Memo Page 2

Print-friendly pdf version (240 K) of Avigan memo (courtesy of psychrights.org)

March 2004 Trontell Memo Re: Mosholder Report

Memo Page 1

Memo Page 2

Print-friendly pdf version (240 K) of Trontell memo (courtesy of psychrights.org)

Mosholder Report Feb 2004: Suicidality in Pediatric Clinical Trials

Page 1: Executive Summary

Page 2: Recommendations

Page 3: Background; Methods

Page 4

Page 5: Results; Bupropion (Wellbutrin, GlaxoSmithKline)

Page 6: Mirtazapine (Remeron, Organon); Fluoxetine (Prozac, Lilly)

Page 7: Nefazodone (Serzone, Bristol Myers Squibb)

Page 8: Fluvoxamine (Luvox, Solvay); Sertraline (Zoloft, Pfizer)

Page 9: Citalopram (Celexa, Forest)

Page 10: Paroxetine (Paxil, GlaxoSmithKline); Venlafaxine (Effexor, Wyeth)

Page 11

Page 12: Risk estimates - Analysis of attributable risk; Table 1. Attributable risks (incidence rate differences) per patient-year for suicide-related events in pediatric trials; Table 2. Attributable risks (incidence rate differences) per patient-year for serious suicide-related events in pediatric trials

Page 13: Analysis of relative risk

Page 14: Discussion and Conclusions; Table 3. Combined incidence rate ratios for suicide-related events and serious suicide-related events

Page 15

Page 16

Page 17: Recommendations

Appendixes

Page 18: Appendix Table 1. Summary of pediatric clinical trial data on suicidal adverse events

Page 19: Appendix Table 2. Rates of suicidal adverse events, per patient-year, in pediatric clinical trials

Page 20: Appendix Table 3. Listing of all patients with suicide-related events in pediatric antidepressant drug trials; Mirtazapine & Fluoxetine

Page 21: Nefazodone, Fluvoxamine, & Sertraline

Page 22: Citalopram

Page 23: Paroxetine

Page 24: Venlafaxine

Page 25: Bupropion (no cases)

Page 28: Appendix table 5. Summary of efficacy findings from eight pediatric antidepressant development programs

Print-friendly pdf version (3.2 MB) of Mosholder report (courtesy of psychrights.org)

return to July 26, 2004 infomail

see also GSK Strategy of Concealment