SSRI & congenital malformations: population based study. published BMJ

Published 23 September 2009, doi:10.1136/bmj.b3569


Cite this as: BMJ 2009;339:b3569



Research





http://www.bmj.com/cgi/content/abstr.../sep23_1/b3569



Selective serotonin reuptake inhibitors in pregnancy and congenital malformations: population based cohort study



Lars Henning Pedersen, research assistant, visiting scholar 1,2, Tine Brink Henriksen, consultant3, Mogens Vestergaard, general practitioner and associate professor4, Jørn Olsen, professor and chair2, Bodil Hammer Bech, associate professor1



1 Department of Epidemiology, Institute of Public Health, Aarhus University, Bartolin Allé 2, DK-8000 Aarhus, Denmark, 2 UCLA School of Public Health, Department of Epidemiology, 650 Charles E Young Drive South, Los Angeles, CA 90095-1772, USA, 3 Department of Paediatrics, Aarhus University Hospital, DK-8200 Aarhus, Denmark, 4 Department of General Practice, Institute of Public Health, Aarhus University, Bartolin Allé 2, DK-8000 Aarhus, Denmark



Correspondence to: Lars Henning Pedersen, Department of Epidemiology, Institute of Public Health, Aarhus University, Bartolins Allé 2, 8000 Aarhus C, Denmark LHP@...



Objective To investigate any association between selective serotonin reuptake inhibitors (SSRIs) taken during pregnancy and congenital major malformations.

Design Population based cohort study.



Participants 493 113 children born in Denmark, 1996-2003.



Main outcome measure Major malformations categorised according to Eurocat (European Surveillance of Congenital Anomalies) with additional diagnostic grouping of heart defects. Nationwide registers on medical redemptions (filled prescriptions), delivery, and hospital diagnosis provided information on mothers and newborns. Follow-up data available to December 2005.



Results Redemptions for SSRIs were not associated with major malformations overall but were associated with septal heart defects (odds ratio 1.99, 95% confidence interval 1.13 to 3.53). For individual SSRIs, the odds ratio for septal heart defects was 3.25 (1.21 to 8.75) for sertraline, 2.52 (1.04 to 6.10) for citalopram, and 1.34 (0.33 to 5.41) for fluoxetine. Redemptions for more than one type of SSRI were associated with septal heart defects (4.70, 1.74 to 12.7)). The absolute increase in the prevalence of malformations was lowfor example, the prevalence of septal heart defects was 0.5% (2315/493 113) among unexposed children, 0.9% (12/1370) among children whose mothers were prescribed any SSRI, and 2.1% (4/193) among children whose mothers were prescribed more than one type of SSRI.



Conclusion There is an increased prevalence of septal heart defects among children whose mothers were prescribed an SSRI in early pregnancy, particularly sertraline and citalopram. The largest association was found for children of women who redeemed prescriptions for more than one type of SSRI.





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