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A pharmacovigilance study of the association between proton pump inhibitors and tumor adverse events based on the FDA adverse event reporting system database

  • 0Department of Pharmacy, The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, Luoyang, China.
Frontiers in Pharmacology +

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January 3, 2025

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January 3, 2025

View abstract on PubMed

Summary

This summary is machine-generated.

Proton pump inhibitors (PPIs) are linked to tumor risks, with gastric cancer being a significant concern. Long-term PPI use requires caution due to potential tumor adverse events (TAEs), necessitating further research into mechanisms and risk factors.

Area Of Science

  • Pharmacovigilance and Drug Safety
  • Oncology
  • Gastroenterology

Background

  • Proton pump inhibitors (PPIs) are widely used for acid-related disorders.
  • Long-term PPI use may be associated with an increased risk of tumor adverse events (TAEs).
  • Existing research on PPI-associated TAEs is limited and inconclusive.

Purpose Of The Study

  • To comprehensively analyze the relationship between PPIs and TAEs.
  • To identify specific tumor types associated with PPI use.
  • To explore demographic factors influencing PPI-associated TAEs.

Main Methods

  • Analysis of PPI adverse reaction reports from the FDA Adverse Event Reporting System (FAERS) database (2004-2024).
  • Focus on five common PPIs: esomeprazole, pantoprazole, lansoprazole, omeprazole, and rabeprazole.
  • Disproportionality analysis using Reporting Odds Ratio (ROR) and univariate logistic regression.

Main Results

  • 3,133 TAEs identified, representing 2.36% of all PPI-related adverse events.
  • Gastric cancer (19.05%) and malignant neoplasm (7.23%) were the most frequent TAEs.
  • Ten significant TAEs identified, including gastric adenocarcinoma and renal cell carcinoma; TAEs were less common in elderly patients.

Conclusions

  • Tumor adverse events (TAEs) are a small but significant concern with PPI use.
  • Long-term PPI therapy warrants cautious consideration due to potential tumor risks.
  • Further research is needed to elucidate mechanisms and identify risk factors for PPI-associated TAEs.

Keywords:

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