Evaluation of the real-world safety of eptifibatide in the treatment of ARDS: results of a disproportionality analysis of FAERS data

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.