Real-world analysis of fibrinolytics-associated bleeding and literature synthesis.

Fibrinolytic agents are essential for acute thrombotic diseases, yet their significant bleeding risks pose a critical clinical challenge, underscoring the need to understand and quantify these risks to optimize outcomes and ensure patient safety. This study leveraged real-world data from the FDA Adverse Event database to analyze global bleeding events associated with fibrinolytic agents from 2004 to 2024. Using disproportionality analysis with multiple complementary statistical algorithms, we identified robust signals linking specific bleeding events to fibrinolytic therapies. The analysis revealed that the majority of bleeding events occurred within the first 30 days of therapy, with severe outcomes such as death, hospitalization, and life-threatening complications predominating. Notably, neurological indications, including ischemic stroke and cerebrovascular accident, exhibited the highest bleeding reporting signal, while significant variations in reporting trends and outcomes were observed across different indications and demographics. Procedural and intracranial bleeding emerged as critical concerns, with strong statistical signals highlighting their clinical relevance. The insights advance the understanding of fibrinolytic-associated bleeding signals and provide an evidence base to support individualized risk-benefit assessments and targeted interventions to enhance patient outcomes in thrombotic disease management.