Evaluation of voriconazole related adverse events in pediatric patients with hematological malignancies


Ertem O., TÜFEKÇİ Ö., ÖREN H., TUNÇOK Y., ERGON M. C., GÜMÜŞTEKİN M.

JOURNAL OF ONCOLOGY PHARMACY PRACTICE, cilt.29, ss.861-873, 2023 (SCI-Expanded) identifier identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 29
  • Basım Tarihi: 2023
  • Doi Numarası: 10.1177/10781552221086887
  • Dergi Adı: JOURNAL OF ONCOLOGY PHARMACY PRACTICE
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Academic Search Premier, Agricultural & Environmental Science Database, CINAHL, EMBASE, International Pharmaceutical Abstracts, MEDLINE
  • Sayfa Sayıları: ss.861-873
  • Anahtar Kelimeler: Voriconazole, invasive fungal infection, adverse events, adverse reactions, pediatrics, LUNG-TRANSPLANT RECIPIENTS, QT INTERVAL PROLONGATION, SQUAMOUS-CELL CARCINOMA, TORSADES-DE-POINTES, INTRAVENOUS VORICONAZOLE, INDUCED PHOTOTOXICITY, ADULT PATIENTS, SKIN, HEPATOTOXICITY, CHILDREN
  • Dokuz Eylül Üniversitesi Adresli: Evet

Özet

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.