Detection and analysis of the safety profile of talazoparib based on FAERS database

Talazoparib was approved for the treatment of breast cancer. However, the safety of talazoparib in a large population sample over an extended period remained uncertain. The objective of this study is to offer guidance for the secure utilization of talazoparib in clinical settings.

Four algorithms were used to quantify the signals of talazoparib associated adverse events(AEs), using data from the food and drug administration adverse event reporting system(FAERS) between fourth quater of 2018 and second quater of 2023.

A total of 7,186,517 records were reported, with 737 indicating talazoparib as the primary suspected (PS) AEs. A total of 40 significant preferred terms (PTs) that adhere to the four algorithms were simultaneously retained. There is a possibility of experiencing unforeseen and noteworthy AEs, including embolism(0.46%), pulmonary embolism(1.06%), hyponatremia(0.46%), hypokalemia(0.40%), hematuria(0.33%), and pericardial effusion(0.26%). Most of the AEs related to talazoparib occurred within the initial month of starting the medication, with a median onset time of 79 days (IQR: 22-207 days).

Results of our study were consistent with clinical observations, and we also found potential new and unexpected AEs signals for talazoparib, suggesting prospective clinical studies were needed to confirm these results and illustrate their relationship. Our results may provide valuable evidence for further safety studies of talazoparib.