Edoxaban and Gastrointestinal haemorrhage: is the FAERS signal real?
Edoxaban ↔ Gastrointestinal haemorrhage
Edoxaban is a direct factor-Xa inhibitor; bleeding is its principal risk and gastrointestinal haemorrhage is a leading site (195 co-reports, PRR 7.4), because the anticoagulated gut mucosa bleeds readily. The ENGAGE AF-TIMI 48 trial showed comparable efficacy to warfarin with less major bleeding overall but a higher rate of gastrointestinal bleeding, and the label warns against use in severe renal impairment and with strong P-glycoprotein inhibitors.
Regulatory basis: edoxaban (Savaysa) prescribing information — bleeding; ENGAGE AF-TIMI 48 trial.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Bleeding follows anticoagulation |
| Strength | met | PRR 7.4, moderate here |
| Consistency | met | Reproduced in ENGAGE AF-TIMI 48 |
| Specificity | partial | Shared across the DOAC class |
| Biological gradient | met | Risk rises with duration and renal impairment |
| Plausibility | met | Direct consequence of factor-Xa inhibition |
| Coherence | met | Fits the mechanism |
| Experiment | met | Randomised trials quantify the excess |
| Analogy | met | Direct class analogy to rivaroxaban and apixaban |
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.
✓ Trial evidence found — Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Nonvalvular Atrial Fibrillation (NVAF) (NCT02072434)
| Adverse event | Edoxaban (n=1067) · Warfarin (n=1082) | |
|---|---|---|
| Lower gastrointestinal haemorrhage | 0/1067 | 1/1082 |
Post-marketing signal terms appear in this trial's posted adverse-event tables; per-arm counts shown as affected/at-risk. View on ClinicalTrials.gov →