Table of Contents
Macrolide Antibiotics and Torsade de Pointes Postmarketing Analysis
Outline
The goal of this analysis is to systematically evaluate postmarketing data in attempt to provide the Advisory Committee with a descriptive overview of Torsade de Pointes in association with macrolide antibiotics.
Telithromycin and Macrolides - Properties Relevant to Postmarketing Analyses
Torsade de Pointes Analysis - Rationale & Public Health Significance
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1. FDA AERS Analysis
Methods
Macrolide Antibiotics and TdP
Demographic/Anthropometric Data
TdP Event Characteristics
Comorbid Risks
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Concomitant Drugs
Clarithromycin and Erythromycin TdP Reports - Contraindicated Drugs
2. IMS HEALTH
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Summary and Conclusions
Postmarketing Summary
Limitations
Advantages
Conclusions
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