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Causality: well established
Causality assessment · Causality: well established
Cabazitaxel and Febrile Neutropenia: 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.
Cabazitaxel ↔ Febrile Neutropenia
n=248 co-reports · PRR 22.7 · ROR 24.4
Lamotrigine is a sodium channel blocker for epilepsy. Suicidal ideation is a recognised but rare adverse effect: lamotrigine carries a label warning about suicidality. 987 co-reports (PRR 21.2) reflect a small but statistically significant signal. The label carries a boxed warning for SJS/TEN and suicidal ideation.
Boxed warning: lamotrigine label (SJS/TEN, suicidal ideation). FDA PI.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in label |
| Strength | met | PRR 21.2 with 987 co-reports |
| Consistency | not established | Not reproduced consistently across anticonvulsant class |
| Specificity | not established | Not specific |
| Biological gradient | not established | No consistent gradient |
| Plausibility | not established | Unknown mechanism |
| Coherence | met | Coherent with some antidepressant literature |
| Experiment | n/a | Not an RCT endpoint |
| Analogy | not established | Not applicable to other anticonvulsants |
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 Cabazitaxel captured febrile neutropenia as a tracked adverse event in a usable structure. Suicidal ideation is a monitored but rare AE; epilepsy RCTs are not powered to detect it.