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Causality: well established
Causality assessment · Causality: well established
Cisplatin and Ototoxicity (hearing loss): 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 ↔ Ototoxicity (hearing loss)
n=415 co-reports · PRR 4.3 · ROR 4.3
Cisplatin damages the hair cells of the inner ear, causing high-frequency hearing loss and sometimes tinnitus that can be permanent and is often worse in children treated for cancer. The injury is cumulative and is why hearing is monitored during and after cisplatin therapy. The 415 co-reports (PRR 4.3) reflect both the real effect and the drug's extensive use in curative chemotherapy regimens.
Regulatory basis: cisplatin prescribing information (ototoxicity warning; audiometric monitoring). Established platinum-ototoxicity literature.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Hearing loss accrues with cumulative dosing and may be permanent |
| Strength | partial | PRR 4 on a large co-report count |
| Consistency | met | Reproduced across oncology and paediatric audiology studies |
| Specificity | met | A recognised platinum-drug effect |
| Biological gradient | met | Cumulative-dose-related, worse in children |
| Plausibility | met | Inner-ear hair-cell damage by platinum is the mechanism |
| Coherence | met | Coheres with the labelled audiometric monitoring |
| Experiment | partial | Dechallenge (dose reduction/withdrawal) limits further loss but does not reverse it; no randomized trial |
| Analogy | met | Analogous to ototoxicity from other platinum drugs and aminoglycosides |
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 deafness or hearing loss as a coded event; the toxicity is detected by audiometry in practice rather than recorded as a trial AE.