Cholestatic hepatitis associated with flucloxacillin

L. E. Derby*, H. Jick, D. A. Henry, A. D. Dean

*Corresponding author for this work

Research output: Contribution to journalArticleResearchpeer-review

58 Citations (Scopus)

Abstract

Objective: To estimate the frequency of cholestatic hepatitis of uncertain origin occurring among persons who had recently received flucloxacillin a drug which has recently been reported as causing cholestatic hepatitis and to compare this frequency with that related to oxytetracycline a drug which has seldom been reported as causing this disorder. Design: A retrospective cohort study using data automatically recorded on general practitioners office computers. Setting: Some 600 general practices in the United Kingdom. Subjects: 132 087 people who received flucloxacillin and 145 844 people who received oxytetracycline. Main outcome measure: Clinically documented cholestatic hepatitis of uncertain origin diagnosed 1-45 days after a prescription for flucloxacillin 46-90 days after a prescription for flucloxacillin and for comparison 1-45 days after a prescription for oxytetracycline. Results: There were 10 cases of cholestatic hepatitis of uncertain origin diagnosed within 45 days of receiving flucloxacillin that were either characteristic of or consistent with a syndrome recently described as being associated with this drug; there was one such case 46-90 days after a prescription for flucloxacillin; there were three such cases 1-45 days after a prescription for oxytetracycline. Conclusion: Flucloxacillin is a likely cause of cholestatic hepatitis. The risk is estimated to be in the range of 7.6 per 100 000 users (95% confidence interval 3.6-13.9).

Original languageEnglish
Pages (from-to)596-600
Number of pages5
JournalMedical Journal of Australia
Volume158
Issue number9
DOIs
Publication statusPublished - 1993
Externally publishedYes

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