Post-marketing safety signals of antifungal agents associated acute kidney injury: pharmacovigilance insights from the fda adverse event reporting system
1
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India
2
Department of General Medicine, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India
3
Department of Pharmacology, Ramaiah University of Applied Sciences, Bangalore, India
Popul. Med. 2026;8(Supplement Supplement 1):A3076
ABSTRACT
INTRODUCTION:
Acute kidney injury (AKI) is a sudden, potentially reversible decline in kidney function, with an incidence of 80 per 1,000 patient years reported in 2007 (1). Nephrotoxic drugs are major contributors, with 14–37% of AKI cases considered drug-induced, and several antifungal agents implicated in renal toxicity (2). This study aimed to identify and characterise antifungal-associated AKI signals using a large pharmacovigilance dataset.
METHODS:
A retrospective case/non case study was conducted using de-duplicated Individual Safety Reports (ISRs) from the OpenVigil 2.1 database. Reports from all age groups and all role codes (primary, secondary suspect, interacting and concomitant) were included. AKI was defined using the MedDRA Preferred Term “acute kidney injury” (version 24.0), and antifungal agents with fewer than three AKI reports were excluded. Disproportionality analysis was performed using the reporting odds ratio (ROR), with 95% confidence intervals. A signal is considered of increased risk when the 95% confidence lower limit for ROR is greater than 1.
RESULTS:
In total, 6,329 drugs contributed 877,364 AKI events; 2,405 drugs (778,218 AKI events) met the signal criteria, including 40 antifungals. After removing duplicates, 23 antifungals with signals of AKI were retained. Imidazole azoles accounted for the highest proportion (53.44%) of AKI events. Triazoles (death: 55.76%, hospitalisation: 57.69%, disability: 80%, and life-threatening events: 63.16%) and polyenes (death: 23.33%, hospitalisation: 19.69%, disability: 20%, and life-threatening events: 21.05%) demonstrated higher proportions of serious outcomes.
CONCLUSIONS:
Multiple antifungal classes are disproportionately associated with reported AKI, with imidazoles, triazoles and polyenes generating safety signal concerns.
Acute kidney injury (AKI) is a sudden, potentially reversible decline in kidney function, with an incidence of 80 per 1,000 patient years reported in 2007 (1). Nephrotoxic drugs are major contributors, with 14–37% of AKI cases considered drug-induced, and several antifungal agents implicated in renal toxicity (2). This study aimed to identify and characterise antifungal-associated AKI signals using a large pharmacovigilance dataset.
METHODS:
A retrospective case/non case study was conducted using de-duplicated Individual Safety Reports (ISRs) from the OpenVigil 2.1 database. Reports from all age groups and all role codes (primary, secondary suspect, interacting and concomitant) were included. AKI was defined using the MedDRA Preferred Term “acute kidney injury” (version 24.0), and antifungal agents with fewer than three AKI reports were excluded. Disproportionality analysis was performed using the reporting odds ratio (ROR), with 95% confidence intervals. A signal is considered of increased risk when the 95% confidence lower limit for ROR is greater than 1.
RESULTS:
In total, 6,329 drugs contributed 877,364 AKI events; 2,405 drugs (778,218 AKI events) met the signal criteria, including 40 antifungals. After removing duplicates, 23 antifungals with signals of AKI were retained. Imidazole azoles accounted for the highest proportion (53.44%) of AKI events. Triazoles (death: 55.76%, hospitalisation: 57.69%, disability: 80%, and life-threatening events: 63.16%) and polyenes (death: 23.33%, hospitalisation: 19.69%, disability: 20%, and life-threatening events: 21.05%) demonstrated higher proportions of serious outcomes.
CONCLUSIONS:
Multiple antifungal classes are disproportionately associated with reported AKI, with imidazoles, triazoles and polyenes generating safety signal concerns.
| eISSN: | 2654-1459 |
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