Cholestatic hepatitis associated with flucloxacillin. Derby, L. E.; Jick, H.; Henry, D. A.; and Dean, A. D. The Medical Journal of Australia, 158(9):596--600, May, 1993. abstract bibtex 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).
@article{derby_cholestatic_1993,
title = {Cholestatic hepatitis associated with flucloxacillin},
volume = {158},
issn = {0025-729X},
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).},
language = {eng},
number = {9},
journal = {The Medical Journal of Australia},
author = {Derby, L. E. and Jick, H. and Henry, D. A. and Dean, A. D.},
month = may,
year = {1993},
pmid = {8479374},
keywords = {Adolescent, Adult, Aged, Aged, 80 and over, Child, Cholestasis, Cohort Studies, Drug-Induced Liver Injury, Female, Floxacillin, Humans, Male, Middle Aged, Oxytetracycline, Retrospective Studies},
pages = {596--600}
}