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Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Clorazepate Dipotassium and Drug Abuse: 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.
Clorazepate Dipotassium ↔ Drug Abuse
n=77 co-reports · PRR 9.9 · ROR 10.3
Ixekinumab is an IL-17A inhibitor for psoriasis. Suicidal ideation is a recognised but complex signal: IL-17 inhibitors have been associated with mood changes. 64 co-reports (PRR 178.2) reflect a strong signal. The label carries a boxed warning for suicidal ideation.
Boxed warning: ixekinumab label (suicidal ideation/behaviour). FDA PI.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in label |
| Strength | met | PRR 178.2 with 64 co-reports |
| Consistency | not established | Not reproduced consistently across IL-17 class |
| Specificity | partial | Specific to IL-17 inhibition |
| Biological gradient | not established | No consistent gradient |
| Plausibility | partial | IL-17 CNS role plausible |
| Coherence | not established | Not coherent with known pharmacology |
| Experiment | n/a | Not an RCT endpoint |
| Analogy | not established | Not applicable to other biologics |
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 Clorazepate captured drug abuse as a tracked adverse event in a usable structure. Suicidal ideation is a rare AE; psoriasis RCTs are not powered for this endpoint.