← All causality assessments
Causality: well established
Causality assessment · Causality: well established
Eptifibatide and Thrombocytopenia: is the FAERS signal real?
A written Bradford Hill assessment of one drug–event pair. The grade is a judgement about the signal, not a statement that this drug causes this event in any one person; FAERS counts are reports, not rates.
Eptifibatide ↔ Thrombocytopenia
n=65 co-reports · PRR 16.0 · ROR 17.4
Eptifibatide is a glycoprotein IIb/IIIa inhibitor given intravenously during percutaneous coronary intervention; by blocking the final common pathway of platelet aggregation it produces both bleeding and, paradoxically, thrombocytopenia (65 co-reports here, PRR 16.0). The thrombocytopenia is acute, antibody-mediated in some cases, and the label requires platelet counts before and during therapy.
Regulatory basis: eptifibatide (Integrilin) prescribing information — thrombocytopenia and bleeding; platelet monitoring.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Platelet fall within hours |
| Strength | met | PRR 16.0, large |
| Consistency | met | Reproduced across GPI experience |
| Specificity | partial | Shared with tirofiban and abciximab |
| Biological gradient | not established | Not clearly dose-related |
| Plausibility | met | Immune-mediated platelet destruction proposed |
| Coherence | met | Fits the anticoagulant picture |
| Experiment | n/a | Not a trial endpoint |
| Analogy | met | Analogous to abciximab thrombocytopenia |
This table is this page's own qualitative read of the literature cited above, not an automated or citation-gated assessment — see the note at the bottom of this page.
✗ No ClinicalTrials.gov results-posting trial in the top search hits for eptifibatide captured thrombocytopenia as a tracked adverse event in a usable structure. PCI trials reported thrombocytopenia as a laboratory safety measure rather than as a coded adverse event.