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Coding artifact: the indication reported back as the "reaction"
Causality assessment · Coding artifact: the indication reported back as the "reaction"
Estrogens, Conjugated and Breast Cancer: 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.
Estrogens, Conjugated ↔ Breast Cancer
n=9,643 co-reports · PRR 40.5 · ROR 48.2
Estrogens, conjugated (CEE) is indicated for menopause. Co-reporting of breast cancer as a reaction is partly an artifact, but the WHI trial of CEE alone did not find elevated breast cancer risk (HR 0.77). 2,590 co-reports (PRR 35.1) are inflated by stimulated reporting after the 2002 WHI findings for combined HRT.
Boxed warning: CEE label. WHI: JAMA 2002.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in label |
| Strength | met | PRR 35.1 (stimulated reporting) |
| Consistency | not established | WHI estrogen-alone showed no increased risk, HR 0.77 |
| Specificity | partial | Specific to estrogen therapy |
| Biological gradient | not established | No consistent gradient |
| Plausibility | partial | Estrogen receptor mechanism |
| Coherence | not established | WHI estrogen-alone contradicted signal |
| Experiment | met | WHI RCT confirmed null |
| Analogy | partial | Analogous to other estrogens |
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 Estrogens, captured breast cancer as a tracked adverse event in a usable structure. The WHI estrogen-alone RCT (n=10,749) directly addressed this.