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Amoxicillin-clavulanate potassium-associated cholestasis
K R Reddy1, P Brillant, E R Schiff
1Department of Medicine, University of Miami School of Medicine, Florida.
Gastroenterology
|April 1, 1989
Summary
Amoxicillin-clavulanate potassium, an antibiotic, can cause liver injury, primarily cholestatic. This often benign hepatic dysfunction resolves after discontinuing the drug.
Area of Science:
- Pharmacology
- Hepatology
- Drug-induced liver injury
Background:
- Amoxicillin-clavulanate potassium is a widely prescribed oral antibiotic.
- Since its 1984 market introduction, millions of prescriptions have been dispensed.
- Post-marketing surveillance has identified cases of jaundice and hepatic dysfunction.
Purpose of the Study:
- To review reported cases of hepatic dysfunction associated with amoxicillin-clavulanate potassium.
- To characterize the pattern and outcome of liver injury.
- To inform clinical recognition and management of this adverse effect.
Main Methods:
- Retrospective review of 18 reported cases of hepatic dysfunction.
- Analysis of clinical presentation, laboratory findings, and liver biopsy results.
- Assessment of outcomes following drug cessation.
Main Results:
- The majority of cases presented with a cholestatic or mixed hepatocellular-cholestatic liver injury pattern.
- No fatalities were reported, and all patients experienced reversal of hepatic dysfunction after drug withdrawal.
- Fever and eosinophilia were observed in some patients, suggesting a potential hypersensitivity component.
- Liver biopsies revealed prominent centrizonal cholestasis in reviewed cases.
Conclusions:
- Amoxicillin-clavulanate potassium can induce a predominantly cholestatic liver injury.
- This hepatic dysfunction is typically benign and reversible upon drug discontinuation.
- Early recognition can prevent unnecessary investigations and guide appropriate patient management.