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Data mining and safety analysis of voriconazole in patients with a hematological malignant tumor based on the FAERS
Hao Li1,2, Manxue Jiang1,2, Xiaona Pan3
1Department of Pharmacy, The First Affiliated Hospital of Bengbu Medical University, Bengbu, China.
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 and 8.5 days, respectively.
Conclusion:
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.
Insights
Voriconazole, an antifungal, showed specific safety concerns in patients with hematological malignancies. Psychiatric disorders were noted in children, while endocrine and hepatobiliary disorders were observed in adults, aiding targeted monitoring.
Area of Science:
- Pharmacovigilance
- Hematology
- Mycology
Background:
- Voriconazole is a critical antifungal for invasive fungal infections in immunocompromised patients, particularly those with hematological malignancies.
- Limited data exists on voriconazole's safety profile in this vulnerable patient population.
- Assessing adverse drug events (ADEs) is crucial for optimizing treatment strategies.
Purpose of the Study:
- To evaluate the safety of voriconazole by analyzing ADEs in patients with hematological malignancies.
- To identify specific safety signals and compare ADE patterns between pediatric and adult patients.
- To enhance the understanding of voriconazole's risk-benefit profile in this population.
Main Methods:
- Utilized the US Food and Drug Administration Adverse Event Reporting System (FAERS) database for ADE reports from 2004-2024.
- Employed four data mining algorithms: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS).
- Classified ADEs using Medical Dictionary for Regulatory Activities (MedDRA) preferred terms (PT) and system organ categories (SOC).
Main Results:
- Analyzed 605 ADEs: 116 in children (19.17%) and 489 in adults (80.83%).
- Identified "psychiatric disorders" as a significant signal in children, and "endocrine disorders" and "hepatobiliary disorders" in adults.
- Observed the highest ROR for "hallucinations, mixed" in children and "toxic optic neuropathy" in adults, with median onset times of 11 and 8.5 days, respectively.
Conclusions:
- Data mining of FAERS identified distinct safety signals for voriconazole in pediatric and adult hematological malignancy patients.
- Psychiatric, endocrine, and hepatobiliary disorders represent key areas for focused monitoring.
- Findings support targeted surveillance to improve voriconazole safety in this high-risk group.
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