Table of Contents
Accutane-Psychiatric Disorders
Presentation Overview
Objectives
Methodological Overview
Presentation Overview
Presentation Overview
Spontaneous Report Case Retrieval
ResultsDistribution 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 Suicidesin Accutane-Exposed Cohort (United States Data and Estimates)
Presentation Overview
ConclusionMood Disorders
ConclusionPsychotic Disorders
ConclusionSuicidal Behavior
Overall Conclusion
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Author: Robert C. Nelson PH.D
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