RISK-FACTORS FOR THE DEVELOPMENT OF AMOXICILLIN-CLAVULANIC ACID ASSOCIATED JAUNDICE

Objectives: To identify risk factors for the development of amoxycilli n-clavulanic acid associated jaundice. Design: Retrospective case-cont rol study, Cases were selected from those reported to the Adverse Drug Reactions Advisory Committee from the time of introduction of amoxyci llin-clavulanic acid to Australia in 1986 until December 1993. Subject s: Thirty-four cases, defined as individuals who developed jaundice wi thin eight weeks of starting amoxycillin-clavulanic acid, with a bioch emical picture of cholestasis, normal calibre bile ducts and no other recognised causes of jaundice or recent use of other hepatotoxic drugs , were selected. For each case, four controls who had been prescribed amoxycillin-clavulanic acid without developing jaundice were randomly selected from the patient register of the prescribing doctor. Results: Increasing age was a risk factor for amoxycillin-clavulanic acid asso ciated jaundice; patients over 55 years had an odds ratio of 16.1. (95 % confidence interval [CI], 2.9-88.9) compared with patients less than 30 years. Men had an odds ratio of 2.5 (95% CI, 1.1-5.4) compared wit h women, although the proportion of men in the study group was larger than in the reported cases overall. History of serious medical illness , drug dose, route and duration of therapy; other medications, smoking and previous drug allergies or use of amoxycillin-clavulanic acid wer e not significantly associated with jaundice. Conclusions: Because of the higher risk of jaundice with increasing age, the risk-benefit rati o of amoxycillin-clavulanic acid should be carefully considered in old er patients, Further assessment is necessary to clarify the associatio n between jaundice and male sex.