Amoxicillin-clavulanic acid hepatotoxicity in children.
OBJECTIVE
The objectives of the present study were to determine the importance of amoxicillin-clavulanic acid (AC) hepatotoxicity in the paediatric population and to characterise the episodes identified and potential host-specific factors. This was addressed via a prospective observational study in which 8 Spanish hospitals participated.


METHODS
A total of 11 cases were examined. For each patient included in the study, a structured and codified data-collection protocol was complied with, taking note of patient demographics, characteristics of the treatment assumed to provoke the reaction, concomitant medication, course and outcome of the episode, and laboratory variables during the reaction. The latter were determined every 6 months from the outset to the eventual resolution of the case.


RESULTS
A total of 11 cases of AC hepatotoxicity were detected, affecting 9 boys and 2 girls, ages 1 to 11 years. Causality criteria were assessed using the Council for International Organizations of Medical Sciences scale.


CONCLUSIONS
We conclude that the introduction of hepatotoxicity record systems in paediatric care, together with the continuing study and development of existing systems, would contribute to improving our epidemiological knowledge about the harmful effects of drugs on the liver.
Hospital Universitario Virgen de las Nieves, España. estherocete@ugr.es
Esther Ocete
EO
Hita
Jose Antonio Martín
JA
García
Jose Carlos Flores
JC
Gonzalez
Ana Abril
AA
Molina
Mjosé Aguilar
MA
Cordero
Javier Salmerón
JS
Escobar
Angela
A
Ruiz-Extremera
D016907:Adverse Drug Reaction Reporting Systems; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000009:adverse effects*; D000900:Anti-Bacterial Agents / Q000009:adverse effects*; D056486:Chemical and Drug Induced Liver Injury / Q000453:epidemiology; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D015994:Incidence; D007223:Infant; D008297:Male; D011446:Prospective Studies; D036301:Qualitative Research; D013030:Spain / Q000453:epidemiology
D000900:Anti-Bacterial Agents; D019980:Amoxicillin-Potassium Clavulanate Combination