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Antibiotics-associated pseudomembranous colitis: a disproportionality analysis of the US food and drug administration

Jinhua Chen1, Weijiang Yu1, Wancun Zhang2

  • 1Department of Pharmacy, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Henan Engineering Research Center for Tumor Precision Medicine and Comprehensive Evaluation, Henan Provincial Key Laboratory of Anticancer Drug Research, Zhengzhou, China.

Expert Opinion on Drug Safety
|April 11, 2024
PubMed
Abstract

Insights

This study identified antibiotics like cefoxitin, streptomycin, fosfomycin, and micafungin as having a high risk for pseudomembranous colitis (PMC). Real-world data analysis highlights potential PMC risks associated with specific antibiotic use.

Area of Science:

  • Pharmacovigilance
  • Infectious Disease Epidemiology
  • Drug Safety

Background:

  • Pseudomembranous colitis (PMC) is a significant concern associated with antibiotic use.
  • Real-world data evaluation is crucial for identifying antibiotics with high PMC risk.

Purpose of the Study:

  • To evaluate the association between specific antibiotics and pseudomembranous colitis (PMC) using real-world data.
  • To identify antibiotics with a disproportionately high risk of PMC.

Main Methods:

  • Utilized the FAERS database for disproportionality analyses.
  • Enrolled 81 antibiotics meeting specific algorithmic criteria.
  • Analyzed 1683 reports of PMC associated with enrolled antibiotics.

Main Results:

  • Identified 1683 PMC reports linked to the studied antibiotics.
  • Cefoxitin, streptomycin, fosfomycin, and micafungin showed a high risk for PMC among the top 24 antibiotics.
  • These high-risk antibiotics had limited existing literature reports regarding PMC.

Conclusions:

  • The study highlights significant potential PMC risks for certain antibiotics.
  • Findings are vital for healthcare professionals to recognize and manage antibiotic-associated PMC risks.
Keywords:
FAERSPseudomembranous colitisadverse eventantibioticdisproportionality analyzes

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