European Journal of Epidemiology

, Volume 30, Issue 11, pp 1187–1198 | Cite as

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

  • Anthony Wemakor
  • Karen Casson
  • Ester Garne
  • Marian Bakker
  • Marie-Claude Addor
  • Larraitz Arriola
  • Miriam Gatt
  • Babak Khoshnood
  • Kari Klungsoyr
  • Vera Nelen
  • Mary O’Mahoney
  • Anna Pierini
  • Anke Rissmann
  • David Tucker
  • Breidge Boyle
  • Lolkje de Jong-van den Berg
  • Helen Dolk


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.


Congenital anomaly SSRI Medication Depression Epidemiology Registry 



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.

Compliance with Ethical Standards


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.

Supplementary material

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Supplementary material 1 (DOCX 16 kb)


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Copyright information

© Springer Science+Business Media Dordrecht 2015

Authors and Affiliations

  • Anthony Wemakor
    • 1
    • 2
  • Karen Casson
    • 1
  • Ester Garne
    • 3
  • Marian Bakker
    • 4
  • Marie-Claude Addor
    • 5
  • Larraitz Arriola
    • 6
  • Miriam Gatt
    • 7
  • Babak Khoshnood
    • 8
  • Kari Klungsoyr
    • 9
    • 10
  • Vera Nelen
    • 11
  • Mary O’Mahoney
    • 12
  • Anna Pierini
    • 13
  • Anke Rissmann
    • 14
  • David Tucker
    • 15
  • Breidge Boyle
    • 1
  • Lolkje de Jong-van den Berg
    • 16
  • Helen Dolk
    • 1
  1. 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 ResearchUlster UniversityNewtownabbeyUK
  2. 2.School of Allied Health SciencesUniversity for Development StudiesTamaleGhana
  3. 3.Hospital LillebaeltKoldingDenmark
  4. 4.Department of Genetics, Eurocat Northern NetherlandsUniversity of Groningen, University Medical Center GroningenGroningenThe Netherlands
  5. 5.Service of Medical Genetics CHUV LausanneLausanneSwitzerland
  6. 6.Public Health Division of Gipuzkoa, Instituto BIO-DonostiaBasque Government, CIBER Epidemiología y Salud Pública - CIBERESPMadridSpain
  7. 7.Department of Health Information and ResearchGuardamangiaMalta
  8. 8.Paris Registry of Congenital MalformationsINSERM U953ParisFrance
  9. 9.Medical Birth Registry of NorwayNorwegian Institute of Public HealthBergenNorway
  10. 10.Department of Global Public Health and Primary CareUniversity of BergenBergenNorway
  11. 11.Provinciaal Instituut voor HygieneAntwerpBelgium
  12. 12.Health Service ExecutiveCorkIreland
  13. 13.Unit of EpidemiologyIFC CNR (Tuscany Registry of Birth Defects)PisaItaly
  14. 14.Malformation Monitoring Centre, Medical FacultyOtto-von-Guericke-University MagdeburgMagdeburgGermany
  15. 15.Congenital Anomaly Register and Information ServicePublic Health WalesSwanseaUK
  16. 16.Department of PharmacyUniversity of GroningenGroningenThe Netherlands

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