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Coding artifact: the indication reported back as the "reaction"
Causality assessment · Coding artifact: the indication reported back as the "reaction"
Conjugated Estrogens And Medroxyprogesterone Acetate and Breast Cancer: is the FAERS signal real?
Conjugated Estrogens And Medroxyprogesterone Acetate side-effect profileAll assessmentsSee in the full list
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.
Conjugated Estrogens And Medroxyprogesterone Acetate ↔ Breast Cancer
n=7,888 co-reports · PRR 81.8 · ROR 122.7
Conjugated estrogens plus medroxyprogesterone (combined HRT) is indicated for menopause. The co-report is partly an artifact, but the WHI trial found a 26 % increased risk of breast cancer (HR 1.26, 95 % CI 1.0–1.6). 7,888 co-reports (PRR 81.8) are inflated by stimulated reporting post-WHI.
Boxed warning: label. WHI: JAMA 2002, PMID: 12483215. Stimulated reporting literature.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in label |
| Strength | met | PRR 81.8 (stimulated reporting) |
| Consistency | met | Reproduced in cohorts |
| Specificity | partial | Specific to combined HRT |
| Biological gradient | met | WHI HR 1.26 |
| Plausibility | partial | Estrogen receptor proliferation |
| Coherence | met | Consistent with WHI |
| Experiment | met | WHI RCT confirmed |
| Analogy | partial | Other combined HRT products |
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 Conjugated captured breast cancer as a tracked adverse event in a usable structure. The WHI RCT (n=16,608) directly addressed this; trial AE capture not needed.