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Causality: well established
Causality assessment · Causality: well established
Cisplatin 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.
Cisplatin ↔ Peripheral neuropathy
n=1,228 co-reports · PRR 3.5 · ROR 3.6
Cisplatin, a platinum chemotherapy drug, damages peripheral nerves, producing numbness, tingling, and sometimes pain that begins in the hands and feet and can be permanent — the effect is cumulative, so the risk rises with every cycle and with total dose. It is a direct consequence of the drug's accumulation in nerve tissue and is a major dose-limiting toxicity. The 1,228 co-reports (PRR 3.5) reflect both the real effect and cisplatin's central role in treating many solid tumours.
Regulatory basis: cisplatin prescribing information (peripheral neuropathy warning; dose limits). Established platinum-neuropathy literature.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Neuropathy develops and worsens with cumulative dosing; may be irreversible |
| Strength | partial | PRR 4 on a large co-report count |
| Consistency | met | Reproduced across oncology practice |
| Specificity | met | A recognised platinum-drug effect, less typical of other chemotherapy |
| Biological gradient | met | Clearly cumulative-dose-related |
| Plausibility | met | Platinum accumulation in dorsal-root ganglia is the mechanism |
| Coherence | met | Coheres with the labelled dose limits and monitoring |
| Experiment | partial | Dechallenge (dose reduction/withdrawal) may stabilise but not reverse it; no randomized trial |
| Analogy | met | Analogous to neuropathy from oxaliplatin and other neurotoxic chemotherapy |
This page's own qualitative read, not an automated/citation-gated assessment.
✗ No ClinicalTrials.gov results-posting trial in the top search hits for cisplatin captured peripheral neuropathy as a coded event; the toxicity is characterised through oncology trials and dose-limit guidance rather than a single trial AE table.