Safety of psychotropic medications in pregnancy: an umbrella review

Nicholas Fabiano¹, Stanley Wong^{1

2}, Arnav Gupta^{3

4}, Jason Tran², Nishaant Bhambra⁵, Kevin K Min⁶, Elena Dragioti⁷, Corrado Barbui⁸, Jess G Fiedorowicz^{9

10

11

12}, Corentin J Gosling^{13

14

15}, Samuele Cortese^{15

16

17

18

19}, Jasmine Gandhi^{9

10

11}, Gayatri Saraf^{9

11

20}, Risa Shorr²¹, Simone N Vigod²², Benicio N Frey^{23

24}, Richard Delorme²⁵, Marco Solmi^{26

27

28

29

30}

Affiliations

¹ SCIENCES Lab, Department of Psychiatry, University of Ottawa, Ottawa, ON, Canada.
² Department of Psychiatry, University of Toronto, Toronto, ON, Canada.
³ Department of Medicine, University of Calgary, Calgary, AB, Canada.
⁴ College of Public Health, Kent State University, Kent, OH, US.
⁵ Department of Family Medicine, University of Ottawa, Ottawa, ON, Canada.
⁶ Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.
⁷ Research Laboratory Psychology of Patients, Families & Health Professionals, Department of Nursing, School of Health Sciences, University of Ioannina, Ioannina, Greece.
⁸ WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona, Verona, Italy.
⁹ Department of Psychiatry, University of Ottawa, Ottawa, ON, Canada.
¹⁰ Department of Mental Health, The Ottawa Hospital, Ottawa, ON, Canada.
¹¹ Ottawa Hospital Research Institute (OHRI) Clinical Epidemiology Program, University of Ottawa, Ottawa, ON, Canada.
¹² School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.
¹³ DysCo Laboratory, Université Paris Nanterre, F9200, Nanterre, France.
¹⁴ Laboratory of Psychopathology and Health Process, Université Paris Cité, F92000, Paris, France.
¹⁵ Centre for Innovation in Mental Health, School of Psychology, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UK.
¹⁶ Clinical and Experimental Sciences (CNS and Psychiatry), Faculty of Medicine, University of Southampton, Southampton, UK.
¹⁷ Solent NHS Trust, Southampton, UK.
¹⁸ Hassenfeld Children's Hospital at NYU Langone, New York University Child Study Center, New York, NY, USA.
¹⁹ DiMePRe-J-Department of Precision and Regenerative Medicine-Jonic Area, University of Bari "Aldo Moro", Bari, Italy.
²⁰ The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.
²¹ Library Services, The Ottawa Hospital, Ottawa, ON, Canada.
²² Department of Psychiatry, Women's, College Hospital and University of Toronto, Toronto, ON, Canada.
²³ Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, ON, Canada.
²⁴ Women's Health Concerns Clinic, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
²⁵ Child and Adolescent Psychiatry Department, Robert Debré Hospital, APHP, University of Paris Cité, Paris, France.
²⁶ SCIENCES Lab, Department of Psychiatry, University of Ottawa, Ottawa, ON, Canada. msolmi@toh.ca.
²⁷ Department of Mental Health, The Ottawa Hospital, Ottawa, ON, Canada. msolmi@toh.ca.
²⁸ Ottawa Hospital Research Institute (OHRI) Clinical Epidemiology Program, University of Ottawa, Ottawa, ON, Canada. msolmi@toh.ca.
²⁹ School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada. msolmi@toh.ca.
³⁰ Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin, Germany. msolmi@toh.ca.

PMID: 39266712
PMCID: PMC11649568
DOI: 10.1038/s41380-024-02697-0

Safety of psychotropic medications in pregnancy: an umbrella review

Nicholas Fabiano et al. Mol Psychiatry. 2025 Jan.

. 2025 Jan;30(1):327-335.

doi: 10.1038/s41380-024-02697-0. Epub 2024 Sep 12.

Authors

Affiliations

¹ SCIENCES Lab, Department of Psychiatry, University of Ottawa, Ottawa, ON, Canada.
² Department of Psychiatry, University of Toronto, Toronto, ON, Canada.
³ Department of Medicine, University of Calgary, Calgary, AB, Canada.
⁴ College of Public Health, Kent State University, Kent, OH, US.
⁵ Department of Family Medicine, University of Ottawa, Ottawa, ON, Canada.
⁶ Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.
⁷ Research Laboratory Psychology of Patients, Families & Health Professionals, Department of Nursing, School of Health Sciences, University of Ioannina, Ioannina, Greece.
⁸ WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona, Verona, Italy.
⁹ Department of Psychiatry, University of Ottawa, Ottawa, ON, Canada.
¹⁰ Department of Mental Health, The Ottawa Hospital, Ottawa, ON, Canada.
¹¹ Ottawa Hospital Research Institute (OHRI) Clinical Epidemiology Program, University of Ottawa, Ottawa, ON, Canada.
¹² School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.
¹³ DysCo Laboratory, Université Paris Nanterre, F9200, Nanterre, France.
¹⁴ Laboratory of Psychopathology and Health Process, Université Paris Cité, F92000, Paris, France.
¹⁵ Centre for Innovation in Mental Health, School of Psychology, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UK.
¹⁶ Clinical and Experimental Sciences (CNS and Psychiatry), Faculty of Medicine, University of Southampton, Southampton, UK.
¹⁷ Solent NHS Trust, Southampton, UK.
¹⁸ Hassenfeld Children's Hospital at NYU Langone, New York University Child Study Center, New York, NY, USA.
¹⁹ DiMePRe-J-Department of Precision and Regenerative Medicine-Jonic Area, University of Bari "Aldo Moro", Bari, Italy.
²⁰ The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.
²¹ Library Services, The Ottawa Hospital, Ottawa, ON, Canada.
²² Department of Psychiatry, Women's, College Hospital and University of Toronto, Toronto, ON, Canada.
²³ Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, ON, Canada.
²⁴ Women's Health Concerns Clinic, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
²⁵ Child and Adolescent Psychiatry Department, Robert Debré Hospital, APHP, University of Paris Cité, Paris, France.
²⁶ SCIENCES Lab, Department of Psychiatry, University of Ottawa, Ottawa, ON, Canada. msolmi@toh.ca.
²⁷ Department of Mental Health, The Ottawa Hospital, Ottawa, ON, Canada. msolmi@toh.ca.
²⁸ Ottawa Hospital Research Institute (OHRI) Clinical Epidemiology Program, University of Ottawa, Ottawa, ON, Canada. msolmi@toh.ca.
²⁹ School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada. msolmi@toh.ca.
³⁰ Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin, Germany. msolmi@toh.ca.

PMID: 39266712
PMCID: PMC11649568
DOI: 10.1038/s41380-024-02697-0

Abstract

Weighing risks and benefits of the use of psychotropic medications during pregnancy remains a challenge worldwide. We systematically assessed the strength of associations between psychotropic medication use in pregnant people with mental disorders and various adverse health outcomes in both pregnant people and foetuses. Systematic reviews with meta-analyses of observational studies investigating the association between exposure to psychotropic medication in pregnancy and any adverse health outcomes were included. Credibility was graded into convincing, highly suggestive, suggestive, weak or not significant. Quality of the meta-analyses and of individual studies were assessed with A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR 2) the Newcastle-Ottawa Scale (NOS), respectively. We considered 21 meta-analyses encompassing 17,290,755 participants (AMSTAR 2 high = 1, low = 12, or critically low = 8). Evidence was suggestive for: (1) preterm birth in pregnant people with either any mental disorder (equivalent odds ratio 1.62 (95% confidence interval 1.24-2.12) or depression (1.65 [1.34-2.02]) receiving antidepressants during any trimester of pregnancy; (2) small for gestational age for pregnant people with depression receiving a SSRI during any trimester of pregnancy (1.50 [1.19-1.90]); and (3) major congenital malformation (1.24 [1.09-1.40]) or cardiac malformations (1.28 [1.11-1.47]) in babies for pregnant people with depression or anxiety receiving paroxetine during first trimester of pregnancy. Additional associations were supported by weak evidence, or were not statistically significant. This umbrella review found no convincing or highly suggestive level of evidence of adverse health outcomes associated with psychotropic medication use in pregnant people with mental disorders.

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Conflict of interest statement

Competing interests: MS received honoraria/has been a consultant for Angelini, Lundbeck, Otsuka. SV reports royalties from UpToDate Inc for authorship of materials related to depression and pregnancy. SC received honoraria from the Association for Child and Adolescent Mental Health (ACAMH), British Association of Psychopharmacology (BAP), Canadian ADHD Resource Alliance (CADDRRA), and Medice.

Figures

**Fig. 1. Study selection flow.**
Flowchart and decision-making process for the inclusion of meta-analyses.

See this image and copyright information in PMC

References

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1. Howland RH. Prescribing psychotropic medications during pregnancy and lactation: principles and guidelines. J Psychosoc Nurs Ment Health Serv. 2009;47:19–23. - PubMed

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Safety of psychotropic medications in pregnancy: an umbrella review

Affiliations

Safety of psychotropic medications in pregnancy: an umbrella review

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

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LinkOut - more resources

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