Adverse events of abemaciclib in breast cancer patients based on US FAERS database

doi:10.19803/j.1672-8629.20240131

Abstract

Abstract: Objective To analyze adverse drug events (ADE) of abemaciclib used in breast cancer patients that were reported in FAERS (FDA Adverse Event Reporting System) database in order to provide clinical data for rational use of this drug among breast cancer patients. Methods Adverse event reports of breast cancer patients using abemaciclib between October 1, 2017 and September 30, 2023 were retrieved from the FAERS before being categorized based on the Medical Dictionary for Regulatory Activities (MedDRA), System Organ Class (SOC), and Preferred Term (PT). Suspected risk signals were analyzed using the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence interval neural propagation network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS). Results After duplicates were excluded, a total of 5 579 ADE of abemaciclib were retrieved. Following screening and analysis, 46 valid signals were identified that were of 16 SOC. The top three ADE were diarrhea, drug ineffectiveness, and dehydration. The top three signal strengths were treatment response loss, milk intolerance, and subcutaneous emphysema. Additionally, 19 suspicious signals, including renal tubular necrosis, kidney injury, sleep disorders (insomnia type), mediastinal emphysema, erythema multiforme, disseminated intravascular coagulation, and transient ischemic attack not mentioned in the product label deserved attention. Conclusion When this medication is adopted, clinicians should also watch for potential ADEs such as renal tubular necrosis and kidney injury that are not listed in the instructions to ensure the safety of the patients.

Key words: abemaciclib, breast cancer, drug adverse reactions, FAERS, active monitoring, drug safety

CLC Number:

SU Xiaohan, ZENG Jiao, LI Xue, LIU Lixin, HOU Lingmi, LI Jinsui. Adverse events of abemaciclib in breast cancer patients based on US FAERS database[J]. Chinese Journal of Pharmacovigilance, 2024, 21(5): 580-586.

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