Accutane-Psychiatric Disorders

9/25/00


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Table of Contents

Accutane-Psychiatric Disorders

Presentation Overview

Objectives

Methodological Overview

Presentation Overview

Presentation Overview

Spontaneous Report Case Retrieval

Results Distribution of Cases By Category

Reasons For Suspecting A Possible Relationship Between A Drug And An Adverse Event

Methodology For Evaluation of Individual Spontaneous Reports

Interpretation of Spontaneous Reports

Mood Disorder Results

Mood Disorder Results (cont’d)

Psychotic Disorder Results

Suicidal Behavior Reports

Presentation Overview

Demographics of Accutane Patients

Prevalence of Major Depressive Disorder (MDD): Age 15-24

MDD Morbidity During Any Six Month Exposure Period

Observed vs Expected

Dose & Time to Onset of Background Occurrences

Estimated Prevalence of Substance Abuse In Accutane-Treated Cohort (15-24 yrs)

Alternate Risk Factors

Psychotic Disorders - Alternate Risk Factors

Suicidal Behavior

Risk of a Serious Suicide Attempt Adjusted for Confounding Mental Disorders, by Gender and Age, for 302 Persons Who Made Serious Suicide Attempts and 1,028 Comparison Subjects

Observed vs Expected Suicides in Accutane-Exposed Cohort (United States Data and Estimates)

Presentation Overview

Conclusion Mood Disorders

Conclusion Psychotic Disorders

Conclusion Suicidal Behavior

Overall Conclusion

Author: Robert C. Nelson PH.D