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Coding artifact: the indication reported back as the "reaction"
Causality assessment · Coding artifact: the indication reported back as the "reaction"
Epirubicin Hydrochloride and Myelosuppression: 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.
Epirubicin Hydrochloride ↔ Myelosuppression
n=695 co-reports · PRR 69.0 · ROR 77.4
Epirubicin is an anthracycline chemotherapy agent. Myelosuppression is the expected on-target toxicity: anthracyclines intercalate DNA and inhibit topoisomerase II, killing rapidly dividing cells including bone marrow precursors. 9,112 co-reports (PRR 28.9) reflect both real myelotoxicity and large chemotherapy population. The label carries a boxed warning for myelosuppression.
Boxed warning: epirubicin label (myelosuppression). Anthracycline chemotherapy literature.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in label |
| Strength | met | PRR 28.9 with 9,112 co-reports |
| Consistency | met | Reproduced across anthracycline class |
| Specificity | partial | Specific to DNA-intercalating agents |
| Biological gradient | met | Correlates with cumulative dose |
| Plausibility | met | Known bone marrow toxicity mechanism |
| Coherence | met | Coherent with chemotherapy pharmacology |
| Experiment | met | Multiple RCTs confirm |
| Analogy | met | Other anthracyclines produce same effect |
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 Epirubicin captured myelosuppression as a tracked adverse event in a usable structure. Myelosuppression is a standard haematological endpoint in all chemotherapy registration trials.