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Evaluation of voriconazole related adverse events in pediatric patients with hematological malignancies.
Ertem, Ozge; Tufekci, Ozlem; Oren, Hale; Tuncok, Yesim; Ergon, Mahmut Cem; Gumustekin, Mukaddes.
Afiliación
  • Ertem O; Medical Pharmacology, University of Health Sciences Izmir Bozyaka Education and Research Hospital, Karabaglar/Izmir, Turkey.
  • Tufekci O; Division of Pediatric Hematology, Department of Pediatrics, Dokuz Eylul University School of Medicine, Balcova/Izmir, Turkey.
  • Oren H; Division of Pediatric Hematology, Department of Pediatrics, Dokuz Eylul University School of Medicine, Balcova/Izmir, Turkey.
  • Tuncok Y; Department of Medical Pharmacology, Dokuz Eylul University School of Medicine, Balcova/Izmir, Turkey.
  • Ergon MC; Department of Medical Microbiology, Dokuz Eylul University School of Medicine, Balcova/Izmir, Turkey.
  • Gumustekin M; Department of Medical Pharmacology, Dokuz Eylul University School of Medicine, Balcova/Izmir, Turkey.
J Oncol Pharm Pract ; 29(4): 861-873, 2023 Jun.
Article en En | MEDLINE | ID: mdl-35285751
BACKGROUND: Despite therapeutic drug monitoring and pharmacogenetic-guided dose selection are recommended for pediatric patients, safety of voriconazole is mostly monitored by clinical assessment. Having comprehensive knowledge of safety profile and distinguishing incidental events from the reactions that are truly related to voriconazole use are crucial for safer and uninterrupted treatment. OBJECTIVES: This study aimed to address adverse reactions during the first month of voriconazole use by systematically evaluating retrospective records of all adverse events. Patients/Methods: It is a single-center, retrospective analysis of patients who received voriconazole from 1 September 2010 to 1 September 2020. Severity of abnormal findings in medical records were systematically graded. Causality between voriconazole and the events was evaluated by Liverpool Causality Assessment Tool (LCAT), Naranjo Algorithm and World Health Organization Causality Assessment System. The events with possible or probable causal relation to voriconazole are classified as adverse reaction. RESULTS: Records of 45 patients included in the study. The overall frequency of adverse reactions was 51.1%. Hepatobiliary laboratory adverse reactions identified in 48.9% of the patients and led to treatment discontinuation in 20.0%. Amylase and lipase elevation (2.2%), ventricular extra systoles (2.2%), hallucination and nightmares (2.2%) were other adverse reactions. CONCLUSIONS: Hepatobiliary abnormalities were the most common adverse reactions and the most common cause of treatment discontinuation. For safer treatment in critically ill patients, the dose should be personalized. To clearly identify the accurate frequency and the causality of all adverse reactions, prospective studies with much larger sample size are needed.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Hematológicas / Antifúngicos Tipo de estudio: Observational_studies / Prognostic_studies Límite: Child / Humans Idioma: En Revista: J Oncol Pharm Pract Asunto de la revista: FARMACIA Año: 2023 Tipo del documento: Article País de afiliación: Turquía Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Hematológicas / Antifúngicos Tipo de estudio: Observational_studies / Prognostic_studies Límite: Child / Humans Idioma: En Revista: J Oncol Pharm Pract Asunto de la revista: FARMACIA Año: 2023 Tipo del documento: Article País de afiliación: Turquía Pais de publicación: Reino Unido