Argatroban and Haemorrhage: is the FAERS signal real?
Argatroban ↔ Haemorrhage
Argatroban is a direct thrombin inhibitor used for heparin-induced thrombocytopenia; by blocking thrombin it impairs clot formation, so bleeding (80 co-reports, PRR 10.7) is the expected dose-related hazard, along with the risk of under-anticoagulation in a prothrombotic condition. Its label requires monitoring of the activated partial thromboplastin time and dose reduction in hepatic impairment.
Regulatory basis: argatroban prescribing information — bleeding; aPTT monitoring.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Bleeding follows anticoagulation |
| Strength | met | PRR 10.7, large |
| Consistency | met | Consistent across case series |
| Specificity | partial | Shared with other anticoagulants |
| Biological gradient | met | Dose-related |
| Plausibility | met | Direct consequence of thrombin inhibition |
| Coherence | met | Fits the mechanism |
| Experiment | n/a | No large randomised trial |
| Analogy | met | Analogous to bivalirudin bleeding |
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 — Multi-arm Optimization of Stroke Thrombolysis (NCT03735979)
| Adverse event | Argatroban (n=59) · Eptifibatide (n=227) · Placebo (n=228) | ||
|---|---|---|---|
| Gastrointestinal haemorrhage | 2/59 | 1/227 | 3/228 |
| Subarachnoid haemorrhage | 0/59 | 5/227 | 3/228 |
| Haemorrhage intracranial | 2/59 | 7/227 | 5/228 |
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 →