Article ; Online: Incidence of amoxycillin-clavulanic acid associated hepatotoxicity in an Australian children's hospital.
The Journal of antimicrobial chemotherapy
2024 Volume 79, Issue 3, Page(s) 589–594
Abstract: Objectives: Amoxycillin/clavulanic acid is the most common antimicrobial cause of drug-induced liver injury in adults. It is a less common cause of severe drug-related hepatotoxicity in children despite its frequent use. We studied the incidence, ... ...
Abstract | Objectives: Amoxycillin/clavulanic acid is the most common antimicrobial cause of drug-induced liver injury in adults. It is a less common cause of severe drug-related hepatotoxicity in children despite its frequent use. We studied the incidence, characteristics and predictive factors for amoxycillin/clavulanic acid hepatoxicity in children. Design: Retrospective cohort study of children who received oral or intravenous amoxycillin/clavulanic acid at a quaternary children's hospital over a 5-year period. Children were included if they had liver function tests (LFTs) determined at baseline, during and within 3 months after the treatment course. Causality was assessed using the Naranjo criteria for adverse drug reactions and Roussel Uclaf Causality Assessment Method. Results: Of 3271 children prescribed amoxycillin/clavulanic acid, 374 were included. Forty-nine (13%) had LFT abnormalities related to amoxycillin/clavulanic acid. Fourteen (3.6%) fulfilled Common Terminology Criteria for Adverse Events (CTCAE) grade 2 criteria with clinically significant hepatotoxicity. Age <2 years, sepsis, post-gastrointestinal surgical indications, prolonged treatment course of >7 days and higher cumulative amoxycillin (>10 g) and clavulanic acid dose (>1 g) were predictive of hepatotoxicity. The median time to resolution of LFT abnormalities was 4 weeks (range 3-7). Conclusions: The incidence of amoxycillin/clavulanic acid related LFT abnormalities (CTCAE Grade 2 or above) in children was 3.6%. A prolonged treatment course >7 days, high cumulative amoxycillin (10 g) and clavulanic acid (>1 g) doses, those aged <2 years, and patients with sepsis or post-gastrointestinal surgery were predictive of a higher likelihood of abnormal LFTs. LFT monitoring should be considered in children receiving ≥7 days of treatment, particularly in those with other predisposing factors. |
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MeSH term(s) | Adult ; Child ; Humans ; Amoxicillin-Potassium Clavulanate Combination/adverse effects ; Clavulanic Acids/adverse effects ; Incidence ; Retrospective Studies ; Drug Therapy, Combination ; Australia/epidemiology ; Amoxicillin/pharmacology ; Clavulanic Acid/adverse effects ; Sepsis/drug therapy ; Drug-Related Side Effects and Adverse Reactions/etiology ; Chemical and Drug Induced Liver Injury/epidemiology ; Chemical and Drug Induced Liver Injury/etiology ; Hospitals |
Chemical Substances | Amoxicillin-Potassium Clavulanate Combination (74469-00-4) ; Clavulanic Acids ; Amoxicillin (804826J2HU) ; Clavulanic Acid (23521W1S24) |
Language | English |
Publishing date | 2024-02-01 |
Publishing country | England |
Document type | Journal Article |
ZDB-ID | 191709-2 |
ISSN | 1460-2091 ; 0305-7453 |
ISSN (online) | 1460-2091 |
ISSN | 0305-7453 |
DOI | 10.1093/jac/dkae009 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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