Eventos adversos a inibidores de tirosina quinase no tratamento da leucemia mieloide crônica no Brasil: análise das notificações do Vigimed

Abstract

Introduction: Tyrosine kinase inhibitors (TKIs) have revolutionized the treatment of Chronic Myeloid Leukemia (CML); however, they are associated with adverse drug reactions (ADRs) that can affect multiple systems. Pharmacovigilance is essential for monitoring drug safety, yet it faces challenges such as incomplete reports, which compromise the identification of risks and the implementation of regulatory measures. Objective: To describe ADR reports related to CML pharmacotherapy recorded in the VigiMed system in Brazil. Method: This is a descriptive study based on the VigiMed database from 2018 to 2021. Variables such as sex, age, type of TKI, seriousness, and ADR profile were evaluated. exploratory data analysis and descriptive statistics (measures of central tendency and proportions) were performed using R and RStudio software. Results: Among 65,534 ADR reports, only 0.3% (n = 196) were related to TKI use. It was observed that 41.6% (n = 15) of the variables had more than 50.0% missing data, most of which were related to information about the medications. Conversely, 30.5% (n = 11) of the variables were complete, predominantly those associated with the reporting process. The drug nilotinib accounted for 57.6% of the reports, followed by imatinib with 41.3%, while no reports were identified for third-generation TKIs. There was a predominance of male individuals (70.4%, n = 138) with a mean age of 55.2 years. Skin and subcutaneous disorders were the most frequently reported events, while hematological disorders were associated with hospitalizations. Conclusions: The study highlights the presence of incomplete data and the need to improve the quality of reports in order to strengthen regulatory actions.