Post-marketing surveillance of the bivalirudin-related adverse events: a two- decade real-world pharmacovigilance study via the FAERS database

Abstract Background Bivalirudin is a widely utilized anticoagulant in coronary surgery. A study aimed to explore potential safety concerns associated with bivalirudin was needed. Aim This study aimed to systematically characterize bivalirudin-associated adverse events and detect emerging safety signals using the FDA adverse event reporting system (FAERS) database. Methods Adverse event reports spanning from the first quarter of 2004 to the second quarter of 2024 were extracted from FAERS database. R 4.4.1 was employed to combine and clean the data. Disproportionality analysis was conducted to assess the adverse event signals linked to bivalirudin. Result The statistical analysis revealed that, in alignment with the information provided on the label, thrombosis and hemorrhage emerged as the most prevalent adverse effects. Significantly, adverse events such as cardiac tamponade, elevated international normalized ratio, and pulmonary hemorrhage, which were noted on the label and reported post-marketing, exhibited considerable signal strength. Furthermore, cardiac conditions including coronary artery occlusion, cardiogenic shock, and acute myocardial infarction warrant close attention. Conclusion This study provides a thorough analysis of the post-marketing adverse effects associated with bivalirudin. Thrombosis, hemorrhage, and cardiac disorders represent significant health risks for patients. It is of great importance to monitor these adverse effects closely on the day of bivalirudin administration.