Use of selective serotonin-reuptake inhibitors during early pregnancy and risk of congenital malformations: updated analysis
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
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 http://creativecommons.org/licenses/by-nc/3.0/. 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: http://www.dovepress.com/permissions.php
Readers of this article also read:
Wong AWY, Zhang C, Chu CH
Published Date: 8 May 2014
Single- and multiple-dose pharmacokinetics, pharmacodynamics, and safety of apixaban in healthy Chinese subjects [Corrigendum]
Cui Y, Song Y, Wang J, Yu Z, Schuster A, Barrett YC, Frost C
Published Date: 27 March 2014
Pharmacokinetics and pharmacodynamics of acetylsalicylic acid after intravenous and oral administration to healthy volunteers
Nagelschmitz J, Blunck M, Kraetzschmar J, Ludwig M, Wensing G, Hohlfeld T
Published Date: 19 March 2014
Kunisawa T, Kasai H, Suda M, Yoshimura M, Sugawara A, Izumi Y, Iida T, Kurosawa A, Iwasaki H
Published Date: 4 March 2014
Gao B, Doan A, Hybertson BM
Published Date: 3 February 2014
Mansour AM, Shahin M, Kofoed PK, Parodi MB, Shami M, Schwartz SG
Published Date: 6 March 2012
Gold M, Lorenzl S, Stewart AJ, Morimoto BH, Williams DR, Gozes I
Published Date: 9 February 2012
Benefit of intravenous antibiotic therapy in patients referred for treatment of neurologic Lyme disease
Stricker RB, DeLong AK, Green CL, Savely VR, Chamallas SN, Johnson L
Published Date: 6 September 2011
Published Date: 18 August 2011
Antiangiogenic drugs in the management of ocular diseases: Focus on antivascular endothelial growth factor
Yukio Sassa, Yasuaki Hata
Published Date: 1 April 2010