Neonatal EPS or withdrawal/adaptation signs have been reported after third-trimester antipsychotic exposure.
- Public-source certainty descriptor
- regulatory class warning; absolute risk unknown
- Formal appraisal
- Not started — full text and independent appraisal pending
- Exposure window
- third trimester/near delivery
- Comparator
- no late antipsychotic exposure
Reported signs include agitation, hypertonia or hypotonia, tremor, somnolence, respiratory distress, and feeding disorder; severity and duration vary, and no reliable incidence is available.
Spontaneous reports, co-medications, illness severity, and no reliable denominator; Cobenfy is mechanistically distinct and excluded from this class claim.
Sources, citation controls, and verification state
Linked sources
- neonatal safetyEXT-076 · 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