Macrolide Antibiotics and Torsade de Pointes Postmarketing Analysis

5/16/01


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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

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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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Supplemental Slides

AERS Reports: Quality and Causation*

Macrolides and TdP: Adjusted Report-Utilization Ratio*

Cardiac Disease

“Surrogate” Cardiac Events Reported*

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Macrolide & Quinolone TdP Reports

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Quinolone Antibiotics and TdP

Demographic/Anthropometric Data

TdP Event* Characteristics

Comorbid Risks

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Author: CDER USER