Pharmacovigilance Signal Detection for Drug-Induced Vanishing Bile Duct Syndrome Using the FDA Adverse Event Reporting System

Tian, X. and Zhao, Y. and Li, G. and Zhu, W. and Yang, D. and Cai, S. and Li, L. (2026) Pharmacovigilance Signal Detection for Drug-Induced Vanishing Bile Duct Syndrome Using the FDA Adverse Event Reporting System. International journal of clinical practice, 2026 (1). (In Press)

Abstract

Background Drug-induced vanishing bile duct syndrome (D-VBDS) is a rare but severe form of liver injury, characterized by progressive bile duct destruction, which remains less well-studied. Methods Data were extracted from the FDA Adverse Event Reporting System (FAERS) for the period Q1 2004 through Q4 2024. Subsequent to rigorous preprocessing and filtering of the reports, pharmacovigilance analyses were conducted, including disproportionality measures and stratified analysis. The Weibull shape parameter was also calculated to evaluate the time-course characteristics of event reporting. Results Strong signal associations were found for drugs including a wide range of antibiotics, such as fluoroquinolones, sulfonamides and related agents, macrolides, tetracyclines, multiple beta-lactams (including penicillins, cephalosporins, and carbapenems), and nitroimidazoles. Common nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, and certain antiretroviral agents, such as nevirapine, also exhibited strong signals. Additionally, positive signals were detected for the C5a inhibitor avacopan; neuropsychiatric medications, including anticonvulsants/antiepileptics; and the selective serotonin reuptake inhibitor (SSRI) sertraline. Distinct sex-specific signal patterns for D-VBDS were also observed. The Weibull shape parameter indicated an early-risk profile for D-VBDS onset following drug initiation. Conclusion This comprehensive pharmacovigilance analysis confirmed numerous potential D-VBDS signals across diverse drug classes, utilizing a large-scale adverse event reporting database.