A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for Niraparib

Abstract

Background Niraparib was approved for the treatment of platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube and primary peritoneal cancer. The authors retrospectively investigated niraparib-related adverse events (AEs) through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS). Methods Four algorithms were employed to quantify the signals of niraparib associated AEs, using data from the FAERS between 2017 and 2021. MYSQL 8.0, Navicat Premium 15, Microsoft EXCEL 2019 and the GraphPad Prism 8 (GraphPad Software, CA, USA) were used to conduct statistical analysis. Results There are 7238157 reports collected from the FAERS database, of which 11701 reports listed niraparib as the ‘primary suspected (PS)’ drug. A total of 97 significant disproportionality PTs conforming to the four algorithms were simultaneously retained. Unexpected significant AEs such as neuropathy peripheral, photosensitivity reaction, gastrooesophageal reflux disease might also occur. The median onset time of niraparib-associated AEs was 18 days (interquartile range [IQR] 4–66 days), and most of the cases occurred within the first months after niraparib initiation. This indicated the need to actively identify and manage AEs during the early stages of niraparib treatment. Conclusion Analysis of FAERS data identified niraparib-associated AEs, which supported continuous clinical monitoring, risk evaluations, and further studies.