First-trimester lithium exposure was associated with a modestly increased cardiac-malformation risk in a large adjusted US cohort.
- Public-source certainty descriptor
- moderate—large observational cohort
- Formal appraisal
- Not started — full text and independent appraisal pending
- Exposure window
- first trimester
- Comparator
- no lithium exposure
Cardiac malformations: 16/663 lithium-exposed infants (2.41%) versus 15,251/1,322,955 unexposed infants (1.15%); adjusted RR 1.65 (95% CI 1.02–2.68). The crude absolute difference is about 1.26 percentage points and is not a causal NNH.
Residual confounding, prescription-fill exposure, and low counts for specific cardiac defects.
Sources, citation controls, and verification state
Linked sources
- risk estimate; dose-responseEXT-057 · Not formally appraised
- guideline recommendation; emergency guideline recommendation; emergency adverse-effect management; guideline decision principle; lactation decision principleEXT-072 · Not formally appraised
- PMID
- Not populated in v0.95
- DOI
- Pending DOI verification
- Exact locator
- Pending exact table/figure/page/supplement locator
- Access date
- 2026-07-29
- Integrity check
- Same-day source surveillance recorded; source-by-source correction/retraction verification remains pending
- Internal verification
- Source-linked; independent external verification pending