Table of Contents
Postmarketing Drug Safety and Risk Intervention Studies
Topics for Today’s Discussion
Why Post-Marketing Surveillance?
Postmarketing Safety Surveillance
Postmarketing Causality Assessment
Postmarketing Causality Assessment
Use of Cases Identified in AERS
Underreporting: Barriers to Reporting
Underreporting of Adverse Drug Reactions From the Literature
Lotronex
Possible Next Steps
Possible Next Steps
Possible Next Steps
First Drug History
First Case History
Risk Intervention Study Objective
Risk Intervention Study Objective
PPT Slide
LT Monitoring at Baseline after the First Prescription by Cohort
Full Compliance with Monthly LT Monitoring by Cohort among Drug Users
Conclusion
Investigators
Second Drug History
Second Drug History
Second Drug History
Study Objective
Methods
Study Sites
Cohorts Before and After Labeling Changes through 6/98
Results: Contraindicated Drug or Disease
Conclusion
Study Group
Summary / Considerations
Future Directions
Future Directions
Future Directions
Back Up Slides
Sample Size of Study Population, UHG
Criteria for Inclusion in the Study Cohort for LT Monitoring
Study Method for Measuring Liver Transaminase Monitoring in UHG
Cohorts
PPT Slide
Contraindicated Drugs
PPT Slide
Contraindicated Comorbidity
Contraindicated Comorbidity
PPT Slide
Future Directions
Future Directions
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