Cholestatic Hepatitis Associated with Flucloxacillin

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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).