Nephrotoxicity in reports of suspected adverse drug events: Descriptive study of data reported to the VigiMed system in 2019

Abstract

Introduction: Nephrotoxicity is a frequent adverse event during medication use, especially in the hospital environment. Its occurrence may occur for reasons inherent to the drug and/or the individual. The main drugs associated with this complication are non-steroidal anti-inflammatory drugs, antimicrobials, antineoplastics, lithium, immunosuppressants, antivirals. In Brazil, the notification of the occurrence of adverse events is reported to the VigiMed system; through notifications it is possible to both monitor the use of medicines and plan health actions. Objective: To describe the therapeutic groups reported as suspected drug-related adverse events received in 2019 by the national pharmacovigilance system in Brazil. Method: Cross-sectional, descriptive, retrospective study made through information from adverse drug event notifications related to nephrotoxicity reported to VigiMed in the period from 01/01/2019 to 12/31/2019. Drugs were classified by the Anatomical Therapeutic Chemical classification system up to the fifth level. Results: 146 notifications reporting nephrotoxicity, with 79 different drugs reported. There was a prevalence of systemic anti-infective agents (group J), 97 (51.05%), mainly antibacterials for systemic use (J01), 70 (36.80%) and antimycotics for systemic use (J02), 18 (9.97%). They were followed by antineoplastic agents and immunomodulators (group L), 30 (16.31%), mainly antineoplastic agents (L01), 23 (12.10%), and the group Various, with contrast (V08), 19 (10.00%). The most frequent medications were Vancomycin, 19, followed by Amphotericin B, 16, and Piperacillin + Tazobactam and Ioexol. Conclusions: The most frequent therapeutic groups in notifications of suspected drug-related adverse events were antibacterials for systemic use, anticancer agents, antimycotics for systemic use and contrast agents.