Pharmacovigilance analysis of glycoprotein IIb/IIIa inhibitors: A FAERS-based signal detection study.

This study compares the safety signals of 3 glycoprotein IIb/IIIa inhibitors (GPIs) - tirofiban, abciximab, and eptifibatide - using the US Food and Drug Administration Adverse Event Reporting System, aiming to guide clinical application. We extracted reports listing the 3 GPIs as the primary suspect from the US Food and Drug Administration Adverse Event Reporting System database. Adverse events were systematically coded using preferred terms and subsequently mapped to system organ classes. To identify potential safety signals, we employed disproportionality analysis algorithms, including the proportional reporting ratio and reporting odds ratio, with predefined thresholds for signal detection. A total of 4911 reports were analyzed (tirofiban: 2352; abciximab: 1295; and eptifibatide: 1264). At the system organ classes level, all 3 GPIs showed positive signals for cardiac disorders, vascular disorders, blood and lymphatic system disorders, and respiratory, thoracic, and mediastinal disorders. Tirofiban demonstrated the strongest cardiovascular signals, followed by abciximab, whereas eptifibatide showed distinct signals in investigations (e.g., laboratory abnormalities) and gastrointestinal disorders. Tirofiban and abciximab also exhibited signals in various nervous system disorders. At the preferred terms level, thrombocytopenia and multi-site hemorrhage were common to all 3 GPIs, consistent with product labeling information. Distinctive signals emerged: tirofiban signals highlighted intracranial hemorrhage and vascular access site bleeding, plus restenosis and reocclusion. Abciximab showed the broadest mucosal bleeding profile (oral, nasal, pharyngeal, otic, conjunctival, and urinary tract) and Mallory-Weiss syndrome. Eptifibatide signals included retroperitoneal hemorrhage, mediastinal hematoma, and bleeding at tracheal, spinal, pelvic, and joint sites, with notable signals for hemorrhagic pancreatitis and anaphylaxis. All 3 GPIs are strongly associated with hemorrhage and thrombocytopenia but differ in risk patterns. Tirofiban signals emphasize cerebrocardiovascular bleeding risks (intracranial and vascular access sites). Eptifibatide signals indicate broader systemic involvement. Abciximab signals highlight oropharyngeal, otorhinolaryngologic, and urinary tract mucosal surfaces. These findings support pharmacovigilance and warrant validation through prospective studies, with the understanding that all reported associations are based on statistical signals from a spontaneous reporting system and do not establish causality.