Thrombotic and ischemic event reporting with anticoagulant reversal agents: a multi-agent FAERS pharmacovigilance study. (PubMed, J Thromb Thrombolysis) - Sep 17, 2026 - "We evaluated thrombotic and ischemic adverse-event reporting for andexanet alfa, idarucizumab, and a prothrombin complex concentrate (PCC) exposure set in the FDA Adverse Event Reporting System (FAERS). FAERS reports showed disproportionate thrombotic and ischemic reporting for all three reversal-agent exposure sets, with a prominent andexanet signal for ischemic stroke. These findings are hypothesis-generating and should not be interpreted as incidence, causality, or a direct comparative clinical-risk estimate."
Adverse events • Journal • Cardiovascular • Hematological Disorders • Ischemic stroke • Thrombosis
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Ertugrul Okuyan; Esra Danisman; Hasan Burak Isleyen; Mahmut Uluganyan; Nusret Acikgoz; Oguzhan Abanoz; Ramazan Ozdemir; Sercan Bulut; Sevil Tugrul Yavuz
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