CNS Drugs

, Volume 32, Issue 4, pp 351–366 | Cite as

The Safety of Second-Generation Antipsychotics During Pregnancy: A Clinically Focused Review

  • Per DamkierEmail author
  • Poul Videbech
Review Article


The issue of antipsychotic treatment during pregnancy is subject to substantial uncertainty and some controversy among healthcare providers, specifically pertaining to second-generation antipsychotics (SGAs) that are subject to a large gap in safety data during pregnancy compared with antidepressants. The amount of safety data for the use of SGAs during pregnancy is rapidly increasing, thus constantly changing the level of evidence. We performed a clinically focused review on the safety of SGA during pregnancy. Twenty-three studies provided various pregnancy outcomes for 14,382 pregnant women exposed to an SGA during pregnancy. In utero exposure to aripiprazole, olanzapine, and quetiapine is not associated with increased risks of major congenital malformations, whereas risperidone and paliperidone may be associated with a very minor increased risk of congenital malformations. Safety data on ziprasidone and clozapine remain scarce and insufficient for a quantitative safety evaluation. No or minimal safety data are available for amisulpride, asenapine, lurasidone, and sertindole. For other pregnancy outcomes of interest, e.g. miscarriage, stillbirth, and small for gestational age, the available data overall do not suggest a clinically important increased risk, and do not allow for a meaningful stratification on individual drug level. Furthermore, for neonatal adaption and childhood neurodevelopment, the data do not allow for a meaningful risk assessment. It is imperative that factors in addition to safety data, e.g. individual disease history, characteristics and treatment response, adverse reaction profile, and patient preferences, be considered for the individual patient when choosing specific SGA treatment during pregnancy.


Compliance with Ethical Standards

This review does not contain individual-level data.

Conflicts of interest

Per Damkier and Poul Videbech declare no conflicts of interest.


This review was not funded.

Supplementary material

40263_2018_517_MOESM1_ESM.docx (13 kb)
Supplementary material 1 (DOCX 12 kb)


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Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Department of Clinical Biochemistry and PharmacologyOdense University HospitalOdenseDenmark
  2. 2.Department of Clinical ResearchUniversity of Southern DenmarkOdenseDenmark
  3. 3.Center for Neuropsychiatric Depression Research, Mental Health Center GlostrupGlostrupDenmark

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