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Causality: well established
Causality assessment · Causality: well established
Bleomycin and Pulmonary fibrosis: 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.
Bleomycin ↔ Pulmonary fibrosis
n=139 co-reports · PRR 20.7 · ROR 21.1
Bleomycin, used in lymphoma and testicular cancer regimens, causes a distinctive dose-dependent lung injury that can progress to pulmonary fibrosis, occasionally fatal. The risk rises with cumulative dose and with age, and is worsened by high inspired oxygen and chest radiotherapy, which is why lung function is followed during therapy. The 139 co-reports (PRR 20.7) reflect both the real, cumulative effect and the drug's narrower use within specialised regimens.
Regulatory basis: bleomycin prescribing information (pulmonary toxicity/fibrosis warning; cumulative-dose limit; lung monitoring).
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Lung injury develops with cumulative dosing and may progress to fibrosis |
| Strength | met | PRR 21 on a modest co-report count |
| Consistency | met | Reproduced across oncology case series |
| Specificity | met | A signature bleomycin effect |
| Biological gradient | met | Clearly cumulative-dose-related |
| Plausibility | met | Oxidative and inflammatory lung injury are the mechanisms |
| Coherence | met | Coheres with the labelled dose limit and lung monitoring |
| Experiment | partial | Dechallenge (withdrawal) may halt progression; no randomized trial |
| Analogy | met | Analogous to pulmonary fibrosis from methotrexate and amiodarone |
This page's own qualitative read, not an automated/citation-gated assessment.
✗ No ClinicalTrials.gov results-posting trial in the top search hits for bleomycin captured pulmonary fibrosis as a coded event; the toxicity is followed by lung-function monitoring rather than recorded as a trial AE.