A disproportionality analysis of real-world adverse events associated with tirofiban from the FAERS database

基于FAERS数据库的替罗非班相关真实世界不良事件比例失衡分析

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Abstract

Tirofiban is a glycoprotein IIb/IIIa receptor blocker mainly used alongside other blood thinners in patients with acute coronary syndrome (ACS) undergoing procedures like angioplasty (PCI). Emerging clinical evidence suggests it may also be beneficial during endovascular treatment for ischemic stroke (IS). Because Tirofiban prevents blood clotting, it is important to assess how often it causes serious bleeding or other side effects when used in real-life settings. We used disproportionality analysis to review all FDA-reported adverse events linked to Tirofiban (from 2004 onward), focusing on cases where the drug was the primary suspect. The study results confirmed known AEs such as bleeding and thrombocytopenia. We observed both commonly reported bleeding events (e.g., brain and gut bleeding) and less commonly recognized types, such as hemothorax and hemorrhagic shock. Furthermore, other relatively rare but statistically significant AEs were identified, including acute respiratory failure, hemolysis, prolonged activated partial thromboplastin time (APTT), coagulopathy, and disseminated intravascular coagulation (DIC). The temporal analysis showed the median onset time of AEs was 1 day, which urges immediate monitoring after drug administration, such as symptom surveillance and complete blood count evaluation.

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