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Abemaciclib-associated kidney injuries: A retrospective analysis of the United States Food and Drug Administration adverse events reporting system
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Abemaciclib-associated kidney injuries: A retrospective analysis of the United States Food and Drug Administration adverse events reporting system
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Journal Article
Abemaciclib-associated kidney injuries: A retrospective analysis of the United States Food and Drug Administration adverse events reporting system
2025
Overview
Background
Abemaciclib, an oral kinase inhibitor, is used to treat hormone receptor–positive and HER2-negative breast cancer patients. However, there has been a decrease in studies reporting adverse reactions to abemaciclib-related kidney injuries. Thus, this study was aimed at assessing its safety profile using a large-scale pharmacovigilance database.
Methods
Abemaciclib-related adverse drug reaction reports from the Food and Drug Administration Adverse Event Reporting System were obtained and scrutinized, and adverse drug reactions were selected using reporting odds ratio, the proportional reporting ratio methods, empirical Bayes geometric mean and UK Medicines and Healthcare products Regulatory Agency methods.
Results
We selected 10,757 matched reports associated with abemaciclib, among which we found eight adverse reactions about kidney injuries correlated with abeamciclib, such as increased blood creatinine, renal disorder, decreased glomerular filtration rate, increased blood urea, hydronephrosis, abnormal renal function test, increased creatinine renal clearance and increased cystatin C. A demographic analysis of reported cases of abemaciclib-associated renal injury revealed that the majority were female, aged ≥46 years and had taken the drug ≥30 days.
Conclusion
This study highlights the characteristics of adverse reactions with abemaciclib and those associated with renal damage, which are crucial for safety studies on the clinical use of this drug.
Plain language summary
Objective
Abemaciclib is an oral kinase inhibitor commonly used to treat hormone receptor–positive and HER2-negative breast cancer. Although it has shown efficacy in treating breast cancer, there have been concerns about its potential to cause kidney injuries. Despite this, studies addressing the adverse effects of abemaciclib on kidney function have been limited. This study aimed to assess the safety profile of abemaciclib, focusing on its association with kidney-related adverse events.
Methods
We conducted a retrospective analysis of adverse drug reactions (ADRs) related to abemaciclib using the Food and Drug Administration Adverse Event Reporting System (FAERS). The study focused on ADRs associated with kidney injuries, and we employed several disproportionality analysis methods to identify potential signals of kidney-related adverse reactions. These methods included the reporting odds ratio (ROR), proportional reporting ratio (PRR), empirical Bayes geometric mean (EBGM), and UK Medicines and Healthcare products Regulatory Agency (MHRA) methods.
Results
Our analysis identified a total of 10,757 reports associated with abemaciclib. Among these, we found eight distinct kidney-related adverse reactions, including increased blood creatinine, renal disorders, decreased glomerular filtration rate, increased blood urea, and abnormal renal function tests. A demographic analysis revealed that the majority of the affected patients were female, over 46 years of age, and had been taking abemaciclib for more than 30 days.
Conclusion
This study provides valuable insights into the kidney-related adverse effects of abemaciclib. The findings suggest that kidney injuries may be an underreported side effect of this medication, particularly among women and those on prolonged treatment regimens. Further research is needed to better understand the renal safety of abemaciclib and to develop guidelines for managing potential kidney-related risks in patients undergoing treatment.
Publisher
SAGE Publications,Sage Publications Ltd,SAGE Publishing
Subject
Acute Kidney Injury - chemically induced
/ Adult
/ Adverse Drug Reaction Reporting Systems - statistics & numerical data
/ Aged
/ Aminopyridines - adverse effects
/ Benzimidazoles - adverse effects
/ Drug-Related Side Effects and Adverse Reactions - epidemiology
/ Female
/ Humans
/ Injuries
/ Kidneys
/ Male
