Erythromycin-associated cholestatic hepatitis.

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).