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Selective serotonin reuptake inhibitor antidepressant use in first trimester pregnancy and risk of specific congenital anomalies: a European register-based study

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Abstract

Evidence of an association between early pregnancy exposure to selective serotonin reuptake inhibitors (SSRI) and congenital heart defects (CHD) has contributed to recommendations to weigh benefits and risks carefully. The objective of this study was to determine the specificity of association between first trimester exposure to SSRIs and specific CHD and other congenital anomalies (CA) associated with SSRI exposure in the literature (signals). A population-based case-malformed control study was conducted in 12 EUROCAT CA registries covering 2.1 million births 1995–2009 including livebirths, fetal deaths from 20 weeks gestation and terminations of pregnancy for fetal anomaly. Babies/fetuses with specific CHD (n = 12,876) and non-CHD signal CA (n = 13,024), were compared with malformed controls whose diagnosed CA have not been associated with SSRI in the literature (n = 17,083). SSRI exposure in first trimester pregnancy was associated with CHD overall (OR adjusted for registry 1.41, 95 % CI 1.07–1.86, fluoxetine adjOR 1.43 95 % CI 0.85–2.40, paroxetine adjOR 1.53, 95 % CI 0.91–2.58) and with severe CHD (adjOR 1.56, 95 % CI 1.02–2.39), particularly Tetralogy of Fallot (adjOR 3.16, 95 % CI 1.52–6.58) and Ebstein’s anomaly (adjOR 8.23, 95 % CI 2.92–23.16). Significant associations with SSRI exposure were also found for ano-rectal atresia/stenosis (adjOR 2.46, 95 % CI 1.06–5.68), gastroschisis (adjOR 2.42, 95 % CI 1.10–5.29), renal dysplasia (adjOR 3.01, 95 % CI 1.61–5.61), and clubfoot (adjOR 2.41, 95 % CI 1.59–3.65). These data support a teratogenic effect of SSRIs specific to certain anomalies, but cannot exclude confounding by indication or associated factors.

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Acknowledgments

We thank the many people throughout Europe involved in providing and processing information, including affected families, clinicians, health professionals, medical record clerks and registry staff.

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Authors and Affiliations

  1. WHO Collaborating Centre for the Epidemiologic Surveillance of Congenital Anomalies, Room 12L23, Centre for Maternal, Fetal and Infant Research, Institute of Nursing and Health Research, Ulster University, Shore Road, Newtownabbey, BT37 0QB, UK

    Anthony Wemakor, Karen Casson, Breidge Boyle & Helen Dolk

  2. School of Allied Health Sciences, University for Development Studies, Tamale, Ghana

    Anthony Wemakor

  3. Hospital Lillebaelt, Kolding, Denmark

    Ester Garne

  4. Department of Genetics, Eurocat Northern Netherlands, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands

    Marian Bakker

  5. Service of Medical Genetics CHUV Lausanne, Lausanne, Switzerland

    Marie-Claude Addor

  6. Public Health Division of Gipuzkoa, Instituto BIO-Donostia, Basque Government, CIBER Epidemiología y Salud Pública - CIBERESP, Madrid, Spain

    Larraitz Arriola

  7. Department of Health Information and Research, Guardamangia, Malta

    Miriam Gatt

  8. Paris Registry of Congenital Malformations, INSERM U953, Paris, France

    Babak Khoshnood

  9. Medical Birth Registry of Norway, Norwegian Institute of Public Health, Bergen, Norway

    Kari Klungsoyr

  10. Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway

    Kari Klungsoyr

  11. Provinciaal Instituut voor Hygiene, Antwerp, Belgium

    Vera Nelen

  12. Health Service Executive, Cork, Ireland

    Mary O’Mahoney

  13. Unit of Epidemiology, IFC CNR (Tuscany Registry of Birth Defects), Pisa, Italy

    Anna Pierini

  14. Malformation Monitoring Centre, Medical Faculty, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany

    Anke Rissmann

  15. Congenital Anomaly Register and Information Service, Public Health Wales, Swansea, Wales, UK

    David Tucker

  16. Department of Pharmacy, University of Groningen, Groningen, The Netherlands

    Lolkje de Jong-van den Berg

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  1. Anthony Wemakor
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  2. Karen Casson
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Correspondence to Helen Dolk.

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Funding

AW was funded by a Ulster University Vice Chancellor’s Research Studentship. EUROCAT is co-funded by the EC, under the framework of the EU Health Programme 2008–2013, Grant Agreement 2010 22 04 (Executive Agency for Health & Consumers). EUROCAT registries are funded as fully described in Paper 6 of EUROCAT Report 9—EUROCAT Member Registries: Organization and Activities.

Conflict of interest

The congenital anomaly registries and institutions where EG, MKB, DT, BK, VN, MoM, AP, MG, MCA, AR, LA, LdJvdB and HD are employed have previously received funding from Glaxo Smith Kline for a study of safety of antiepileptic lamotrigine use in pregnancy. No author has had any association with or interest in any antidepressant manufacturer in relation to the current study.

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Wemakor, A., Casson, K., Garne, E. et al. Selective serotonin reuptake inhibitor antidepressant use in first trimester pregnancy and risk of specific congenital anomalies: a European register-based study. Eur J Epidemiol 30, 1187–1198 (2015). https://doi.org/10.1007/s10654-015-0065-y

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