The Safety of Second-Generation Antipsychotics During Pregnancy: A Clinically Focused Review
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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.
- 1.McAllister-Williams RH, Baldwin DS, Cantwell R, Easter A, Gilvarry E, Glover V, et al. British Association for Psychopharmacology consensus guidance on the use of psychotropic medication preconception, in pregnancy and postpartum 2017. J Psychopharmacol (Oxford). 2017;31:519–52.CrossRefGoogle Scholar
- 3.ACOG Committee on Practice Bulletins—Obstetrics. ACOG Practice Bulletin: Clinical management guidelines for obstetrician-gynecologists number 92, April 2008 (replaces practice bulletin number 87) Use of psychiatric medications during pregnancy and lactation. Obstet Gynecol. 2007;2008(111):1001–20.Google Scholar
- 5.Hasan A, Falkai P, Wobrock T, Lieberman J, Glenthøj B, Gattaz WF, et al. World federation of societies of biological psychiatry (WFSBP) guidelines for biological treatment of schizophrenia. Part 3: Update 2015 Management of special circumstances: Depression, Suicidality, substance use disorders and pregnancy and lactation. World J Biol Psychiatry. 2015;16:142–70.CrossRefPubMedGoogle Scholar
- 10.Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling. Federal Register. 2014 [cited 14 Nov 2017]. Available at: https://www.federalregister.gov/documents/2014/12/04/2014-28241/content-and-format-of-labeling-for-human-prescription-drug-and-biological-products-requirements-for.
- 11.Guideline on the exposure to medicinal products during pregnancy: need for post-authorisation data [cited 14 Nov 2017]. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/11/WC500011303.pdf.
- 29.Cohen LS, Viguera AC, McInerney KA, Freeman MP, Sosinsky AZ, Moustafa D, et al. Reproductive safety of second-generation antipsychotics: current data from the massachusetts general hospital national pregnancy registry for atypical antipsychotics. Am J Psychiatry. 2016;173:263–70.CrossRefPubMedGoogle Scholar
- 34.Bayley N. Bayley Scale of infant and toddler development. 3rd ed. San Antonio: The Psychological Corp; 2006.Google Scholar
- 39.Centers for Disease Control and Prevention. (CDC). Update on overall prevalence of major birth defects—Atlanta, Georgia, 1978-2005. MMWR Morb Mortal Wkly Rep. 2008;57:1–5.Google Scholar
- 43.Dev V, Krupp P. Adverse event profile and safety of clozapine. Rev Contemp Pharmacother. 1995;6:197–208.Google Scholar
- 44.Bazire S. Psychotropic drug directory. Salisbury: Fivepin Limited; 2005.Google Scholar
- 50.Damkier P, Pottegård A, dePont Christensen R, Hallas J. Annotations and reflections: pregnancy and paracetamol: methodological considerations on the study of associations between in utero exposure to drugs and childhood neurodevelopment. Basic Clin Pharmacol Toxicol. 2015;116:2–5.CrossRefPubMedGoogle Scholar