Clinical Safety Profile OTC Omeprazole Magnesium (Prilosec 1TM)

10/25/00


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Table of Contents

Clinical Safety Profile OTC Omeprazole Magnesium (Prilosec 1TM)

Safety Profile Issues

Outline of Talk

Outline of Talk (Cont.)

Adverse Events - Short-term Exposure 4 Databases

OTC Trials (n=8,179)

OTC Omeprazole Side-effects

Short Term Toxicity

Liver Injury

Hepatitis Incidence

Liver Toxicity Post-Marketing

Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome

White Blood Cell Suppression Incidence

White Blood Cell Suppression SafeTNet

Hypersensitivity

Hypersensitivity (SafeTNet) Serious Adverse Events

Hypersensitivity

Swedish Post-Marketing 1998-1999 Voluntary Reporting

Swedish Post-Marketing 1998-1999 Summary

Effects on Drug Clearance

Drug-Drug Interactions

Adolescents

Safety in Adolescents

Embryo-Fetal Damage

Adverse Events - Long-Term Exposure

Concern on Long-Term OTC Use

Masking of Gastric Malignancy

GERD Complications

GERD Complications

GERD: Standard of Medical Care*

GERD: Standard of Medical Care*

GERD Management Summary

GERD Management

Is Omeprazole Tumorigenic in Humans?

Omeprazole Induced Hypergastrinemia

Omeprazole Induced Hypergastrinemia

Genotoxicity

Genotoxicity Summary

Difficulties in Determining Carcinogenicity of Omeprazole

Difficulties in Determining Carcinogenicity of Omeprazole

Evidence to Date of Carcinogenicity Summary of Clinical Studies, SafeTNet and Literature

Rebound of Gastric Acid Secretion

Rebound of Gastric Acid Secretion

Summary of Safety Issues

Summary of Safety Issues

Summary of Safety Issues

Summary of Safety Issues

Summary of Safety Issues

Summary of Safety Issues Long-term use

Summary of Safety Issues Long-term use

Safety:Risk Management

Safety:Risk Management

PPT Slide

Author: CDER User