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Related Experiment Videos

Cholestatic hepatitis associated with flucloxacillin

L E Derby1, H Jick, D A Henry

  • 1Boston Collaborative Drug Surveillance Program, Boston University Medical Center, Lexington, MA 02173-5207.

The Medical Journal of Australia
|May 3, 1993
PubMed
Summary

Flucloxacillin is a likely cause of cholestatic hepatitis, with an estimated risk of 7.6 per 100,000 users. This study compared flucloxacillin-induced liver injury to oxytetracycline.

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Area of Science:

  • Hepatology
  • Clinical Pharmacology
  • Drug-Induced Liver Injury

Background:

  • Cholestatic hepatitis is a liver condition characterized by impaired bile flow.
  • Flucloxacillin, an antibiotic, has been anecdotally linked to cholestatic hepatitis.
  • Oxytetracycline has rarely been associated with this liver disorder.

Observation:

  • A retrospective cohort study was conducted across 600 UK general practices.
  • Data from 132,087 flucloxacillin users and 145,844 oxytetracycline users were analyzed.
  • Cases of cholestatic hepatitis were identified within 1-45 and 46-90 days post-prescription.

Findings:

  • Ten cases of cholestatic hepatitis were diagnosed within 45 days of flucloxacillin use.
  • One case was observed 46-90 days after flucloxacillin prescription.

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  • Three cases were identified within 45 days of oxytetracycline prescription.
  • Implications:

    • Flucloxacillin is strongly implicated as a cause of cholestatic hepatitis.
    • The estimated risk of flucloxacillin-induced cholestatic hepatitis is 7.6 per 100,000 users.
    • This research highlights the importance of monitoring for drug-induced liver injury.