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Causality: well established
Causality assessment · Causality: well established
Thalidomide 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.
Thalidomide ↔ Peripheral neuropathy
n=1,823 co-reports · PRR 11.3 · ROR 11.8
Thalidomide carries a boxed warning for peripheral neuropathy, a dose- and duration-related axonal injury that may be irreversible and is often the dose-limiting toxicity; 1,823 co-reports give PRR 11.3. The label advises baseline and periodic neurological assessment.
Regulatory basis: thalidomide prescribing information — boxed warning for peripheral neuropathy.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Months of therapy, cumulative |
| Strength | met | PRR 11.3 with 1,823 co-reports |
| Consistency | met | Reproduced across cohorts |
| Specificity | met | Fairly specific to thalidomide |
| Biological gradient | met | Strong cumulative-dose relation |
| Plausibility | met | Known axonal toxicity |
| Coherence | met | Fits thalidomide neurotoxicity |
| Experiment | n/a | Neuropathy is a coded trial endpoint |
| Analogy | met | Analogous to bortezomib neuropathy |
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.
✓ Trial evidence found — Pomalidomide for the Treatment of Bleeding in HHT (NCT03910244)
| Adverse event | Placebo (n=49) · Pomalidomide (n=95) | |
|---|---|---|
| Neuropathy peripheral | 0/49 | 2/95 |
Post-marketing signal terms appear in this trial's posted adverse-event tables; per-arm counts shown as affected/at-risk. View on ClinicalTrials.gov →