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Published on: December 22, 2023
Evaluating cardiac disorders associated with triazole antifungal agents based on the US Food and Drug Administration
Jinhua Chen1, Shijun Xu2, Weijiang Yu1
1Department of Pharmacy, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Henan Engineering Research Center for Tumor Precision Medicine and Comprehensive Evaluation, Henan Provincial Key Laboratory of Anticancer Drug Research, Zhengzhou, China.
Introduction:
Triazole antifungal agents are widely used to treat and prevent systemic mycoses. With wide clinical use, the number of reported adverse events has gradually increased. The aim of this study was to analyze the cardiac disorders associated with TAAs (fluconazole, voriconazole, itraconazole, posaconazole and isavuconazole) based on data from the US Food and Drug Administration Adverse Event Reporting System FDA Adverse Event Reporting System.
Methods:
Data were extracted from the FAERS database between the first quarter of 2004 and third quarter of 2022. The clinical characteristics in TAA-associated cardiac AE reports were analyzed. Disproportionality analysis was performed to evaluate the potential association between AEs and TAAs using the reporting odds ratio (ROR) and proportional reporting ratio (PRR).
Results:
Among 10,178,522 AE reports, 1719 reports were TAA-associated cardiac AEs as primary suspect drug. Most reports were related to fluconazole (38.34%), voriconazole (28.56%) and itraconazole (26.76%). Itraconazole (N = 195, 42.39%) and isavuconazole (N = 2, 14.29%) had fewer serious outcome events than three other drugs including fluconazole, voriconazole, and posaconazole. 13, 11, 26, 5 and 1 signals were detected for fluconazole, voriconazole, itraconazole, posaconazole and isavuconazole, respectively. The number of new signals unrecorded in the drug label was 9, 2, 13, 2 and 0 for fluconazole, voriconazole, itraconazole, posaconazole and isavuconazole, respectively.
Conclusion:
Isavuconazole might be the safest of the five TAAs for cardiac AEs. TAA-associated cardiac disorders may result in serious adverse outcomes. Therefore, in addition to AEs on the drug label, we should pay attention to new AEs unrecorded on the drug label during the clinical use of TAAs.
Insights
Triazole antifungal agents (TAAs) can cause cardiac adverse events. Isavuconazole appears safest for cardiac safety, but new, unrecorded side effects warrant clinical attention.
Area of Science:
- Pharmacovigilance
- Cardiology
- Mycology
Background:
- Triazole antifungal agents (TAAs) are crucial for treating systemic fungal infections.
- Increasing clinical use of TAAs has led to a rise in reported adverse events.
- Cardiac disorders are a significant concern associated with TAA therapy.
Purpose of the Study:
- To analyze cardiac disorders linked to five TAAs: fluconazole, voriconazole, itraconazole, posaconazole, and isavuconazole.
- To assess the safety profile of these TAAs regarding cardiac adverse events using real-world data.
- To identify potential new cardiac safety signals not listed on current drug labels.
Main Methods:
- Utilized data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) from Q1 2004 to Q3 2022.
- Analyzed clinical characteristics of TAA-associated cardiac adverse event reports.
- Employed disproportionality analysis (ROR, PRR) to detect safety signals.
Main Results:
- Out of over 10 million AE reports, 1719 were TAA-associated cardiac AEs.
- Fluconazole, voriconazole, and itraconazole accounted for the majority of reports.
- Isavuconazole showed fewer serious outcomes and new cardiac safety signals compared to other TAAs.
Conclusions:
- Isavuconazole may possess a more favorable cardiac safety profile among the studied TAAs.
- TAA-associated cardiac disorders can lead to severe outcomes.
- Vigilance for unrecorded cardiac adverse events during TAA use is essential.
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