Eptifibatide use in ARDS patients was associated with known adverse events such as bleeding, thrombocytopenia, hypotension, and identified novel potential adverse reactions including hemorrhagic pancreatitis, coronary artery reocclusion, stent thrombosis, anisocoria, brain herniation, and cardiac arrest according to FAERS data analysis.
Real-world pharmacovigilance data confirms known bleeding risks of eptifibatide and identifies potential new safety signals including hemorrhagic pancreatitis, coronary artery reocclusion, and brain herniation.
Background Acute respiratory distress syndrome (ARDS) is a clinical syndrome with an extremely high mortality rate, and antiplatelet therapy is an important treatment approach. Eptifibatide, a glycoprotein IIb/IIIa receptor inhibitor (GPI), is primarily used to treat acute coronary syndrome (ACS) and non-venous thromboembolic pulmonary embolism, as well as for antiplatelet therapy in conditions such as ARDS and septic shock. With its increasing clinical application, understanding its safety profile in real-world settings is essential. Methods This study evaluated the clinical safety of Eptifibatide by analyzing all adverse event (AEs) reports in the FDA Adverse Event Reporting System (FAERS) where Eptifibatide was listed as the primary suspected drug since 2004. Analytical methods included the Bayesian Confidence Propagation Neural Network (BCPNN), the UK Medicines and Healthcare Products Regulatory Agency (MHRA) comprehensive standard method, the Multi-item Gamma Poisson Shrinker (MGPS), the Proportional Reporting Ratio (PRR), and the Reporting Odds Ratio (ROR). Results The study confirmed known adverse reactions of Eptifibatide, such as bleeding, intracranial hemorrhage, stroke, thrombocytopenia, allergic reactions, immunogenicity, and hypotension, which are also listed in the drug's prescribing information. Additionally, some previously unmentioned adverse reactions were identified, including acute myocardial infarction, cardiac arrest, nausea, hemorrhagic pancreatitis, chills, dyspnea, and vascular pseudoaneurysm. The study also highlighted the importance of early detection of adverse reactions to Eptifibatide. Conclusion This research provides insights into both known and potential adverse reactions associated with Eptifibatide in real-world clinical use, offering additional safety information for clinicians when prescribing Eptifibatide for ARDS treatment.
Zhang et al. (Thu,) conducted a other in Patients with acute respiratory distress syndrome (ARDS) treated with eptifibatide as primary suspected drug (n=1,263). Eptifibatide was evaluated on Incidence and profile of adverse events related to eptifibatide reported in FAERS including bleeding, thrombocytopenia, hypotension, and novel reactions. Eptifibatide use in ARDS patients was associated with known adverse events such as bleeding, thrombocytopenia, hypotension, and identified novel potential adverse reactions including hemorrhagic pancreatitis, coronary artery reocclusion, stent thrombosis, anisocoria, brain herniation, and cardiac arrest according to FAERS data analysis.