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Cholestatic hepatitis due to antibacterial combination of amoxicillin and clavulanic acid (augmentin)
B H Stricker1, J W Van den Broek, J Keuning
1Netherlands Centre for Monitoring of Adverse Reactions to Drugs, Rijswijk.
Abstract:
Five case histories are presented of patients developing cholestatic hepatitis associated with the intake of the antibiotic combination agent amoxicillin and clavulanic acid (Augmentin). In two of these cases, signs of hepatic injury recurred after readministration of this combination but not after the intake of amoxicillin alone. In none of the patients was another cause for cholestatic hepatitis found and extrahepatic causes were excluded by ultrasonography, CT scanning, or ERCP. Most viral causes of hepatic injury were excluded in these patients. With the exception of one patient, who developed a transient rash, no immunoallergic signs were present. Biopsy in two patients showed extensive cholestasis without significant necrosis. Clavulanic acid seems to be responsible for this adverse effect.
Insights
This study reports five cases of cholestatic hepatitis linked to amoxicillin and clavulanic acid (Augmentin). Evidence suggests clavulanic acid is the likely cause of this antibiotic-induced liver injury.
Area of Science:
- Hepatology
- Pharmacology
- Internal Medicine
Background:
- Antibiotic use is common, but drug-induced liver injury (DILI) remains a concern.
- Amoxicillin and clavulanic acid is a widely prescribed antibiotic combination.
- Cholestatic hepatitis is a potential adverse drug reaction.
Purpose of the Study:
- To investigate cases of cholestatic hepatitis potentially associated with amoxicillin and clavulanic acid.
- To identify the component of the antibiotic combination responsible for hepatic injury.
- To differentiate drug-induced liver injury from other causes of hepatitis.
Main Methods:
- Case series presentation of five patients with cholestatic hepatitis.
- Clinical history review, including medication intake and adverse reactions.
- Exclusion of other causes of hepatitis through laboratory tests, imaging (ultrasonography, CT), and ERCP.
- Liver biopsy analysis in two patients.
Main Results:
- Five patients developed cholestatic hepatitis after taking amoxicillin and clavulanic acid.
- Two patients experienced recurrent hepatic injury upon re-challenge with the combination, but not with amoxicillin alone.
- No alternative causes for hepatitis were identified, and immunoallergic signs were minimal.
- Liver biopsies showed cholestasis without significant necrosis.
Conclusions:
- Amoxicillin and clavulanic acid is a potential cause of cholestatic hepatitis.
- Clavulanic acid is implicated as the causative agent in this adverse drug reaction.
- Healthcare providers should be aware of this potential side effect when prescribing this antibiotic combination.