Macrolide Antibiotics and Torsade de PointesPostmarketing Analysis

5/16/01

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Table of Contents

Macrolide Antibiotics and Torsade de PointesPostmarketing Analysis

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

1. FDA AERS Analysis

Macrolide Antibiotics and TdP

Demographic/Anthropometric Data

TdP Event Characteristics

Concomitant Drugs

Clarithromycin and Erythromycin TdP Reports - Contraindicated Drugs

Summary and Conclusions

Postmarketing Summary

Supplemental Slides

AERS Reports: Quality and Causation*

Macrolides and TdP:Adjusted Report-Utilization Ratio*

Cardiac Disease

“Surrogate” Cardiac Events Reported*

Macrolide & Quinolone TdP Reports

Quinolone Antibiotics and TdP

Demographic/Anthropometric Data

TdP Event* Characteristics

Author: CDER USER