[Liver damage associated with the combination drug amoxicillin-clavulanic acid (Augmentin)].

OBJECTIVE

To describe the case histories of patients with liver damage associated with the antibacterial combination amoxicillin-clavulanic acid.

DESIGN

Descriptive.

SETTING

University Institute for General Practice, Rotterdam, the Netherlands.

METHOD

All reports (n = 40) of hepatic injury, attributed to amoxicillin-clavulanic acid (causal relationship 'possible', 'probable' or 'certain') and received by the Drug Safety Unit of the Inspectorate for Health Care since the registration of the combination (1982) until August 1996 were described and evaluated.

RESULTS

The reports concerned 28 men and 12 women with an average age of 61 years who had used the drug mostly for a respiratory tract infection. The latency period between first in-take and onset of the reaction was 3 weeks on average. The mean duration of hepatic injury was approximately 6 weeks. The liver injury resolved fully. Five patients had had the reaction on more than one occasion. The main symptoms were jaundice, nausea, pruritus and abdominal pain. The pattern of hepatic injury was mostly cholestatic or mixed hepatocellular-cholestatic.

CONCLUSION

Since liver damage to amoxicillin-clavulanic acid appears to be infrequent, this adverse effect is probably not caused by amoxicillin alone. The risk of liver damage to amoxicillin-clavulanic acid is highest in elderly patients treated with the combination on several occasions. Doctors should restrict the use of this combination to the treatment of infections with amoxicillin-resistant bacteria.