Back to Browse Journals » Clinical Epidemiology » Volume 2

Use of selective serotonin-reuptake inhibitors during early pregnancy and risk of congenital malformations: updated analysis

Authors Jette B Kornum, Rikke B Nielsen, Lars Pedersen, et al

Published 17 March 2010 Volume 2010:2 Pages 29—36


Review by Single-blind

Peer reviewer comments 5

Jette B Kornum1, Rikke B Nielsen1, Lars Pedersen1, Preben B Mortensen2, Mette Nørgaard1

1Department of Clinical Epidemiology, Aarhus University Hospital, Denmark; 2National Center for Registry-based Research, University of Aarhus, Aarhus, Denmark

Background: Data on the safety of selective serotonin-reuptake inhibitors (SSRIs) in pregnancy are inconsistent. We examined associations between SSRI use during early pregnancy and risk of congenital malformations in infants.

Methods: Set in Northern Denmark, our population-based prevalence study included 216,042 women who had a live birth after the 20th week of gestation. We compared the prevalence of malformation in infants born to women who redeemed at least one SSRI prescription during early pregnancy with the prevalence in infants born to women who redeemed no SSRI prescriptions during their pregnancies. Drug use data were extracted from prescription databases, while data on congenital malformations were obtained from the National Registry of Patients.

Results: The 2,062 women with SSRI prescriptions during early pregnancy gave birth to 105 (5.1%) infants with malformations, while the 213,712 women with no SSRI prescriptions gave birth to 7,449 (3.5%) infants with malformations. SSRI use was associated with an increased risk of malformations overall (odds ratio [OR] = 1.3; 95% confidence interval (CI): 1.1–1.6) and cardiac malformations (OR = 1.7; 95% CI: 1.1–2.5). For specific SSRIs, we found an increased risk for septal defects associated with sertraline.

Conclusions: We found little overall association between use of SSRIs during pregnancy and congenital malformations, but our findings suggest an association between maternal SSRI use in early pregnancy and cardiac malformations which could be causal.
Keywords: antidepressants, drug safety, pregnancy, congenital malformations, epidemiology

Download Article [PDF] 

Creative Commons License This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution - Non Commercial (unported, v3.0) License. The full terms of the License are available at Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on how to request permission may be found at:

Readers of this article also read:

A new recombinant factor VIII: from genetics to clinical use

Kannicht C, Kohla G, Tiemeyer M, Walter O, Sandberg H

Drug Design, Development and Therapy 2015, 9:3817-3819

Published Date: 23 July 2015

Development of acquired factor V inhibitor after treatment with ceftazidime: a case report and review of the literature

Cui QY, Shen HS, Wu TQ, Chen HF, Yu ZQ, Wang ZY

Drug Design, Development and Therapy 2015, 9:2395-2398

Published Date: 24 April 2015

A new recombinant factor VIII: from genetics to clinical use

Santagostino E

Drug Design, Development and Therapy 2014, 8:2507-2515

Published Date: 12 December 2014

Managing hemophilia: the role of mobile technology

Khair K, Holland M

Smart Homecare Technology and TeleHealth 2014, 2:39-44

Published Date: 6 May 2014

The use of PEGylated liposomes in the development of drug delivery applications for the treatment of hemophilia

Rivka Yatuv, Micah Robinson, Inbal Dayan-Tarshish, et al

International Journal of Nanomedicine 2010, 5:581-591

Published Date: 6 August 2010

Evidence supporting the use of recombinant activated factor VII in congenital bleeding disorders

Pär I Johansson, Sisse R Ostrowski

Drug Design, Development and Therapy 2010, 4:107-116

Published Date: 29 June 2010

Critical appraisal of the role of recombinant activated factor VII in the treatment of hemophilia patients with inhibitors

Ampaiwan Chuansumrit, Pantep Angchaisuksiri, Nongnuch Sirachainan

Journal of Blood Medicine 2010, 1:37-48

Published Date: 30 March 2010

Does plasmin have anticoagulant activity?

Jane Hoover-Plow

Vascular Health and Risk Management 2010, 6:199-205

Published Date: 26 March 2010