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
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