ERYTHROMYCIN-ASSOCIATED CHOLESTATIC HEPATITIS

Objective: To estimate the risk of cholestatic hepatitis of uncertain origin in patients who had recently received erythromycin, a drug whic h is known to cause this disorder. Design: A retrospective cohort stud y using data automatically recorded on general practitioners' office c omputers. Setting: Some 600 general practices in the United Kingdom. S ubjects: 366 064 people who received erythromycin. Main outcome measur e: Clinically documented cholestatic hepatitis of uncertain origin dia gnosed 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 characteris tic of or consistent with a syndrome previously described as being ass ociated with this drug. Conclusion: The risk of cholestatic jaundice a ssociated with erythromycin is estimated to be in the range of 3.6 per 100 000 users (95% confidence interval, 1.9-6.1).