Drug‐Associated Nephrotic Syndrome: A Global Pharmacovigilance Perspective

Abstract

Introduction: Nephrotic syndrome is a rare clinical manifestation, with an estimated incidence of 3 cases per 100 000 population per year, which can be triggered by medications contributing to the development of its histopathological forms. The literature references various drugs such as antibiotics, allopurinol, pamidronate, sirolimus, among others. Pharmacovigilance studies enable the evaluation of the safety of these medications in large populations, identifying drugs most strongly associated with the phenotype under investigation.
Methods: This study involved the detection of notifications related to the development of nephrotic syndrome in VigiBase, and assessed the available data based on frequency, disproportionality, and their nephrotoxic role.
Results: During the selected period and among 37 145 123 available notifications, 7211 notifications related to drug‐associated nephrotic syndrome were filtered using the appropriate MedDRA term. These predominantly affected male consumers aged 45‐64 years, with the majority of notifications originating from the USA. Medications classified un‐ der ATC class L‐ antineoplastic and immunomodulating agents, were most frequently involved, and with penicillamine showing the highest association with this phenotype (ROR 231.28), followed by inotersen (ROR 24.49) and sunitinib (ROR 20.31), among others. These notifications had a mortality of 4.2%, with proton pump inhibitors being frequently implicated.
Conclusion: This study assessed VigiBase for the primary medications involved in the development of nephrotic syndrome, both in terms of frequency and associative strength. Clinician involvement is crucial in increasing notifications of adverse drug reactions. Understanding the main agents involved in various renal phenotypes helps improve prescription practices and ensures greater patient safety.