Objectives: 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
†Hospital Universitario San Cecilio, Granada
‡Hospital Universitario Virgen del Mar, Cádiz, España.
Address correspondence and reprint requests to Esther Ocete Hita, Hospital Universitario Virgen de las Nieves, Granada, Spain (e-mail: email@example.com).
Received 28 September, 2011
Accepted 25 May, 2012
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Members of the Spanish Multicenter project “Pilot Study of Liver Disease Drug-Associated in Pediatrics”: R.J. Andrade Bellido (Hospital Virgen de la Victoria, Málaga), Jimena Castillo Peral (Hospital Universitario Gregorio Marañón, Madrid), Francisco Jiménez Sánchez (Hospital Torrecárdenas, Almería), Ignacio Ibarra de la Rosa (Hospital Reina Sofia, Cordoba), M.I. Lucena Gonzalez (Hospital Virgen de la Victoria, Málaga), F. Martinón Torres (Hospital Clínico Universitario de Santiago), and J. Romero González (Hospital Materno Infantil Virgen de las Nieves, Granada).
The authors report no conflicts of interest.