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Causality: well established
Causality assessment · Causality: well established
Efavirenz and Suicidal depression: 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.
Efavirenz ↔ Suicidal depression
n=36 co-reports · PRR 19.9 · ROR 19.9
Efavirenz carries a boxed warning for serious psychiatric symptoms including depression and suicidality, which can occur at any time during therapy; 36 co-reports give PRR 19.9. Patients are warned to report mood change, and the drug is stopped if symptoms are severe.
Regulatory basis: efavirenz (Sustiva) prescribing information — boxed warning for psychiatric symptoms and suicidality.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Any time on therapy |
| Strength | met | PRR 19.9 with 36 co-reports |
| Consistency | met | Reproduced across cohorts |
| Specificity | not established | Depression is common in the population |
| Biological gradient | not established | Not clearly dose-related |
| Plausibility | met | Plausible CNS mechanism |
| Coherence | met | Fits efavirenz neuropsychiatric effects |
| Experiment | n/a | Rarely coded as a trial endpoint |
| Analogy | met | Analogous to other antiretroviral CNS effects |
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 efavirenz captured suicidal depression as a tracked adverse event in a usable structure. Trials under-reported psychiatric adverse events and coded suicidality poorly.