Phenylpropanolamine & Risk of Hemorrhagic Stroke

10/30/00


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Table of Contents

Phenylpropanolamine & Risk of Hemorrhagic Stroke

Plan

Background

Background 1984

Background 1991: ADRs reported with CVA

Background 1991

Background 1991

Case Review 2000

Case Review 2000

Typical Case Report

Underreporting of Cases

The Hemorrhagic Stroke Project (HSP)

HSP Case-control Study - PPA & Hemorrhagic Stroke

Objectives contd.

Study Design

Design Strengths

Design Limitations

Small Sample Size (CHPA)

Small Sample Size (FDA)

Potential Confounders

Odds Ratios for Hemorrhagic Stroke with PPA Use in Subjects without Hypertension & without Aphasia

Misclassification (CHPA)

Misclassification (FDA)

Surrogate Responders (CHPA)

Surrogate Responders (FDA)

Surrogate Responders (FDA) contd

FDA Analyses

HSP Study Results

Public Health Impact

Total Number of PPA dose units sold annually by OTC status

Total Number PPA dose units sold annually by indication*

Public Health Impact

Public Health Impact

Public Health Impact

Annual Public Health Impact 18 - 49 years

Public Health Impact

Criteria for Causal Association

Strength of Association

Dose Response

Biological Plausibility

Blood Pressure Response to PPA Challenge in a Large Population

Consistency with Other Knowledge

Summary

Conclusions

Team: OPDRA/ Office of Biostatistics

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Back-up slides

Pseudoephedrine (PSE) Hemorrhagic Stroke cases

Time Dependent Relationship between PPA and Hemorrhagic Stroke

Relationship between the Time Contour of PPA Risk and Relative Risk

Public Health Impact

Public Health Impact contd

Public Health Impact -Attributable Risk Calculation

Case Definition Hemorrhagic Stroke

Exposure Definition/Ascertainment

Strategies for Reducing Recall Bias

Total Number PPA dose units sold annually*

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Sensitivity Analysis for Addressing Bias due to Sparse Data

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Author: CDER USER