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Causality: well established
Causality assessment · Causality: well established
Lamotrigine and Stevens-Johnson syndrome: 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.
Lamotrigine ↔ Stevens-Johnson syndrome
n=2,615 co-reports · PRR 21.2 · ROR 21.6
Lamotrigine carries a warning for serious skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, strongly associated with rapid titration and HLA-B*1502; 2,615 co-reports give PRR 21.2. The label mandates slow titration and stopping at the first sign of rash.
Regulatory basis: lamotrigine prescribing information — serious skin rash/SJS/TEN warning; titration guidance.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | First 8 weeks of therapy |
| Strength | met | PRR 21.2 with 2,615 co-reports |
| Consistency | met | Reproduced across cohorts |
| Specificity | met | Associated with HLA alleles |
| Biological gradient | met | Titration-related |
| Plausibility | met | Immune-mediated mechanism |
| Coherence | met | Fits aromatic-anticonvulsant risk |
| Experiment | n/a | Too rare for trial detection |
| Analogy | met | Analogous to carbamazepine and phenytoin SJS |
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 lamotrigine captured stevens-johnson syndrome as a tracked adverse event in a usable structure. A rare idiosyncratic eruption cannot be detected in randomised trials.