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Causality: well established
Causality assessment · Causality: well established
Vincristine and Peripheral neuropathy: 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.
Vincristine ↔ Peripheral neuropathy
n=645 co-reports · PRR 4.9 · ROR 5.0
Vincristine is a vinca alkaloid that causes a dose-limiting peripheral sensory-motor neuropathy, with loss of deep-tendon reflexes to frank weakness; 645 co-reports give PRR 4.9. The label warns of neurotoxicity and caps the dose.
Regulatory basis: vincristine prescribing information — peripheral neuropathy; dose limitation.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Days to weeks |
| Strength | met | PRR 4.9 with 645 co-reports |
| Consistency | met | Consistent across cohorts |
| Specificity | met | Fairly specific to vinca alkaloids |
| Biological gradient | met | Dose-related |
| Plausibility | met | Known microtubule mechanism |
| Coherence | met | Fits vincristine neurotoxicity |
| Experiment | n/a | Often monitored in trials |
| Analogy | met | Analogous to other vinca neuropathies |
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 vincristine captured peripheral neuropathy as a tracked adverse event in a usable structure. Neurotoxicity is expected, but graded clinically and confounded by other neurotoxic chemotherapy.