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Do drugs with biliary toxicity cause cholangiocarcinoma?

Cai Zong1,2, Kyumin Lim1,3, Sierra A Walker1

  • 1Center for Systems Biology, Massachusetts General Hospital, Boston, MA 02114, USA.

Biorxiv : the Preprint Server for Biology
|April 10, 2026
PubMed

Insights

This study investigated if common drugs like Augmentin cause cholangiocarcinoma (CCA). Researchers found no direct causal link between Augmentin use and CCA development in patients.

Area of Science:

  • Hepatology and Gastroenterology
  • Drug-induced Liver Injury
  • Oncology

Background:

  • Biliary toxicity is a known side effect of many drugs.
  • The increasing incidence of cholangiocarcinoma (CCA) raises questions about potential drug involvement.

Purpose of the Study:

  • To investigate a potential causal relationship between commonly used drugs, specifically Augmentin, and the development of cholangiocarcinoma (CCA).
  • To assess if Augmentin or other drugs contribute to CCA incidence.

Main Methods:

  • Experimental analysis in cholangiocytes using single extracellular vesicle (EV) analysis.
  • Cohort study analyzing CCA incidence in a healthcare system.
  • Statistical analysis including relative risk (RR) and Fisher's exact test.

Main Results:

  • Augmentin did not increase cholangiocyte malignancy markers (YAP1 or phospho-YAP1).
  • CCA incidence was numerically higher in the Augmentin group (0.0932%) but not statistically significant compared to amoxicillin (0.0799%).
  • No evidence of CCA development was found for other tested drugs (chlorpromazine, floxuridine, 5-fluorouracil, flucloxacillin, terbinafine).

Conclusions:

  • There is no direct causal relationship between clinical Augmentin doses and CCA development.
  • Commonly prescribed drugs, including Augmentin, do not appear to directly cause cholangiocarcinoma.
Keywords:
antibioticcancercholangiocarcinomadrug toxicity

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