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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Pharmacoepidemiology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1524702
This article is part of the Research Topic Advances in Drug-induced Diseases Volume II View all 38 articles

Data mining and safety analysis of voriconazole in patients with a hematological malignant tumor based on the FAERS database: differences between children and adults

Provisionally accepted
Hao Li Hao Li Jiang Manxue Jiang Manxue Xiaona Pan Xiaona Pan Lingti Kong Lingti Kong *
  • The first affiliated hospital of Bengbu medical university, Bengbu, China

The final, formatted version of the article will be published soon.

    Objective: Voriconazole is a broad-spectrum antifungal agent. It is used widely for the prevention and treatment of invasive fungal infections in patients with a hematological malignancy, but studies on its safety in this population are scarce. We assessed the adverse drug events (ADEs) of voriconazole in this population based on the US Food and Drug Administration Adverse Event Reporting System (FAERS) database to improve understanding of the safety of voriconazole.Research design and methods: ADE reports for patients with a hematological malignant tumor using voriconazole between the first quarter of 2004 to the first quarter of 2024 were retrieved. Then, they were classified using the preferred terminology (PT) and system organ category (SOC) in the Medical Dictionary for Regulatory Activities. Data mining was done using reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS).Results: A total of 605 ADEs were included: 116 (19.17%) in children and 489 (80.83%) in adults.The types of SOC involved in children and adults were 22 and 24, respectively. The only positive SOC signal that satisfied all four algorithms simultaneously in children was "psychiatric disorders", whereas in adults they were "endocrine disorders" and "hepatobiliary disorders". At the PT level, the types involved in children and adults were 28 and 74, respectively. The highest ROR signal intensities were found for "hallucinations, mixed" in children and "toxic optic neuropathy" in adults.The median time of onset of the ADE in children and adults was 11 days and 8.5 days, respectively.We used four algorithms (ROR, PRR, BCPNN, MGPS) to mine the signals of voriconazole in patients with a hematological malignant tumor, and compared the differences between children and adults. This study is important for targeting the monitoring, and could help to improve the safety of voriconazole.

    Keywords: Data Mining, Voriconazole, Hematological malignant tumor, FAERS, Children, adults

    Received: 08 Nov 2024; Accepted: 09 Jan 2025.

    Copyright: © 2025 Li, Manxue, Pan and Kong. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Lingti Kong, The first affiliated hospital of Bengbu medical university, Bengbu, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.