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. 2024 Jun;52(3):891-899.
doi: 10.1007/s15010-023-02132-6. Epub 2023 Nov 23.

Antibiotic-associated vanishing bile duct syndrome: a real-world retrospective and pharmacovigilance database analysis

Jianglin Wang  1 , Shengfeng Wang  1 , Cuifang Wu  1 , Zhenzhen Deng  2
Affiliations

Antibiotic-associated vanishing bile duct syndrome: a real-world retrospective and pharmacovigilance database analysis

Jianglin Wang et al. Infection. 2024 Jun.

Abstract

Purpose: Vanishing bile duct syndrome (VBDS) is a rare, but potentially fatal adverse reaction triggered by certain medications. Few real-world studies have shown association between antibiotics and VBDS. We sought to quantify the risk and evaluate the clinical features of VBDS associated with antibiotics.

Methods: Data from 2004 to 2022 on VBDS events induced by antibiotics were retrieved from the FDA Adverse Event Reporting System (FAERS) database and disproportionality analyses were conducted. Furthermore, case reports from 2000 to 31 December 2022 on antibiotics-induced VBDS were retrieved for retrospective analysis.

Results: We collected 132 VBDS reports from the FAERS database. Fluoroquinolones had the greatest proportion and highest positive signal values of VBDS. The RORs (95% CIs) for antibiotics were fluoroquinolones 23.68 (18.12-30.95), macrolides 19.37 (13.58-27.62), carbapenems 17.39 (7.77-38.96), beta-lactam 13.28 (9.69-18.20), trimethoprim/sulfamethoxazole 9.05 (5.57-14.7), and tetracycline 4.02 (1.50-10.77). Twenty-three cases from 22 studies showed evidence of VBDS, beta-lactam (52.2%) was the most frequently reported agent. The median age was 45 years, the typical initial symptoms included rash (30.4%), fatigue/asthenia (26.1%), dark urine (21.7%) and Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) (21.7%). The median time to onset of VBDS was 2 weeks. All cases had abnormal liver function test, and the median level of total bilirubin was 23.6 mg/dl (range 3.2-80 mg/dl). Cessation of culprit drugs and treatment with ursodeoxycholic acid (83.3%) were not associated with improved outcomes (57.1%).

Conclusion: This study identified thirteen antibacterial agents with significant reporting associations with VBDS. Fluoroquinolones may be a neglected agent of inducing VBDS.

Keywords: Adverse drug reaction; Antibiotics; Drug safety; FAERS database; Vanishing bile duct syndrome (VBDS).

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References

    1. Desmet VJ. Vanishing bile duct syndrome in drug-induced liver disease. J Hepatol. 1997;26(Suppl 1):31–5. - PubMed - DOI
    1. Reau NS, Jensen DM. Vanishing bile duct syndrome. Clin Liver Dis. 2008;12:203–17. - PubMed - DOI
    1. Ahmad J, Barnhart HX, Bonacini M, et al. Value of liver biopsy in the diagnosis of drug-induced liver injury. J Hepatol. 2022;76:1070–8. - PubMed - PMC - DOI
    1. Rockey DC, Caldwell SH, Goodman ZD, Nelson RC, Smith AD. Liver Biopsy Hepatol. 2009;49:1017–44.
    1. Geubel AP, Sempoux CL. Drug and toxin-induced bile duct disorders. J Gastroenterol Hepatol. 2000;15:1232–8. - PubMed

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