Erythromycin-associated cholestatic hepatitis

Abstract

Objective: To estimate the risk of cholestatic hepatitis of uncertain origin in patients who had recently received erythromycin, a drug which is known to cause 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: 366,064 people who received erythromycin.

Main outcome measure: Clinically documented cholestatic hepatitis of uncertain origin diagnosed 1-45 days after a prescription for erythromycin.

Results: There were 13 cases of cholestatic hepatitis of uncertain origin diagnosed within 45 days of receiving erythromycin which were either characteristic of or consistent with a syndrome previously described as being associated with this drug.

Conclusion: The risk of cholestatic jaundice associated with erythromycin is estimated to be in the range of 3.6 per 100,000 users (95% confidence interval, 1.9-6.1).