← All causality assessments
Coding artifact: the indication reported back as the "reaction"
Causality assessment · Coding artifact: the indication reported back as the "reaction"
Lomustine and Thrombocytopenia: 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.
Lomustine ↔ Thrombocytopenia
n=180 co-reports · PRR 13.4 · ROR 14.3
Clozapine is an atypical antipsychotic for schizophrenia. Suicidal ideation is a complex outcome: clozapine is the only antipsychotic indicated for suicidality in schizophrenia. Co-reporting likely reflects detection bias in psychiatric populations. 233 co-reports (PRR 23.7) overrepresent monitoring rather than causation.
Label: clozapine PI. J. Clin Psychiatry 2018, PMID: 29113853.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in label |
| Strength | met | PRR 23.7 with 233 co-reports |
| Consistency | not established | Contradicted by clozapine indication for suicidality |
| Specificity | not established | Not specific |
| Biological gradient | not established | No gradient |
| Plausibility | partial | Known pharmacology |
| Coherence | not established | Indication is to reduce suicidality |
| Experiment | n/a | Clozapine RCTs measure suicidality |
| Analogy | partial | Other antipsychotics differ |
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 Lomustine captured thrombocytopenia as a tracked adverse event in a usable structure. Clozapine is the only antipsychotic indicated for reducing suicidality; co-reports reflect detection bias.