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Causality: well established
Causality assessment · Causality: well established
Dabigatran and Gastrointestinal bleeding: 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.
Dabigatran ↔ Gastrointestinal bleeding
n=8,281 co-reports · PRR 29.6 · ROR 33.0
Dabigatran is a direct oral thrombin inhibitor, so bleeding — especially from the gut — is the expected hazard of any effective anticoagulant, and dabigatran's particular propensity for gastrointestinal bleeding relative to warfarin is well documented. Because a large fraction of the drug remains in the gut with its tartaric-acid excipient, the risk is partly local as well as systemic. The 8,281 co-reports (PRR 29.6) reflect the enormous population on oral anticoagulants and the severity of bleeding that drives reporting.
Regulatory basis: dabigatran prescribing information (bleeding warning); RE-LY randomized trial versus warfarin.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Bleeding occurs during anticoagulation and is managed by stopping the drug |
| Strength | met | PRR 30 on a very large co-report count |
| Consistency | met | Reproduced in the randomized RE-LY trial and in real-world cohorts |
| Specificity | partial | An anticoagulant-class effect, with dabigatran's GI rate above warfarin in some analyses |
| Biological gradient | partial | Risk rises with dose, renal impairment, age, and interacting drugs |
| Plausibility | met | Blocking thrombin impairs haemostasis — bleeding is the pharmacodynamic extension |
| Coherence | met | Coheres with the bleeding-focused labelling and monitoring |
| Experiment | met | Randomized evidence (RE-LY) and co-therapy studies directly quantify the risk |
| Analogy | met | Analogous to bleeding with warfarin, rivaroxaban, and apixaban |
This page's own qualitative read, not an automated/citation-gated assessment.
✗ The results-posting dabigatran trials that surfaced recorded gastrointestinal bleeding only as isolated events (e.g. 1 versus 0 in NCT00558259); the bleeding excess is quantified by the large randomized outcome trial RE-LY and real-world cohorts, not by a single trial AE table.