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Eur J Epidemiol. 2015 Nov;30(11):1187-98. doi: 10.1007/s10654-015-0065-y. Epub 2015 Jul 7.

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

Author information

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.
2
School of Allied Health Sciences, University for Development Studies, Tamale, Ghana.
3
Hospital Lillebaelt, Kolding, Denmark.
4
Department of Genetics, Eurocat Northern Netherlands, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
5
Service of Medical Genetics CHUV Lausanne, Lausanne, Switzerland.
6
Public Health Division of Gipuzkoa, Instituto BIO-Donostia, Basque Government, CIBER EpidemiologĂ­a y Salud PĂșblica - CIBERESP, Madrid, Spain.
7
Department of Health Information and Research, Guardamangia, Malta.
8
Paris Registry of Congenital Malformations, INSERM U953, Paris, France.
9
Medical Birth Registry of Norway, Norwegian Institute of Public Health, Bergen, Norway.
10
Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.
11
Provinciaal Instituut voor Hygiene, Antwerp, Belgium.
12
Health Service Executive, Cork, Ireland.
13
Unit of Epidemiology, IFC CNR (Tuscany Registry of Birth Defects), Pisa, Italy.
14
Malformation Monitoring Centre, Medical Faculty, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.
15
Congenital Anomaly Register and Information Service, Public Health Wales, Swansea, Wales, UK.
16
Department of Pharmacy, University of Groningen, Groningen, The Netherlands.
17
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. H.Dolk@ulster.ac.uk.

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.

KEYWORDS:

Congenital anomaly; Depression; Epidemiology; Medication; Registry; SSRI

PMID:
26148560
DOI:
10.1007/s10654-015-0065-y
[Indexed for MEDLINE]

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