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Updated: May 20, 2026

Multimodal Quantitative Phase Imaging with Digital Holographic Microscopy Accurately Assesses Intestinal Inflammation and Epithelial Wound Healing
07:38

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Immunomodulatory therapies and emerging drug associations with microscopic colitis: A global pharmacovigilance

Yaron Cohen1, Andreas Münch2, Asaf Levartovsky3

  • 1Department of Military Medicine, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.

Digestive and Liver Disease : Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
|May 18, 2026
PubMed
Abstract

Insights

This study identified new drug associations with microscopic colitis (MC), highlighting immunomodulatory drugs as significant risk factors. Findings offer practical guidance for clinicians managing MC patients.

Area of Science:

  • Pharmacovigilance and drug safety research.
  • Gastroenterology and immunology.
  • Clinical pharmacology.

Background:

  • Microscopic colitis (MC) is linked to immune dysregulation, with drug exposure as a key risk factor.
  • Identifying current drug associations with MC is crucial for patient safety.

Purpose of the Study:

  • To identify contemporary associations between drug use and microscopic colitis (MC).
  • To update understanding of drug-induced MC risk.

Main Methods:

  • A decade-long pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) database (July 2014-June 2024).
  • Assessed disproportionate reporting of MC using reporting odds ratios (RORs), adjusting for patient demographics and concomitant medications.

Main Results:

  • 2,648 MC cases were linked to 55 medications from over 12 million safety reports.
  • Biologic and synthetic immunosuppressants (e.g., tocilizumab, leflunomide, methotrexate) showed significant MC risk.
  • Immune checkpoint inhibitors, traditional MC agents (PPIs, SSRIs, NSAIDs), and other drug classes also emerged as associated with MC.

Conclusions:

  • This study provides a comprehensive map of drug-MC associations, revealing novel safety signals.
  • Immunomodulatory drugs are substantial risk factors for microscopic colitis.
  • Findings offer practical insights for clinicians in managing patients with MC.
Keywords:
ColitisImmune-mediated intestinal diseasesImmunomodulatory drugsMicroscopic colitisPharmacovigilance

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