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. 2012 Jun 18;2(3):e001148.
doi: 10.1136/bmjopen-2012-001148. Print 2012.

Exposure to selective serotonin reuptake inhibitors and the risk of congenital malformations: a nationwide cohort study

Espen Jimenez-Solem  1 , Jon Traerup Andersen, Morten Petersen, Kasper Broedbaek, Jonas Krogh Jensen, Shoaib Afzal, Gunnar H Gislason, Christian Torp-Pedersen, Henrik Enghusen Poulsen
Affiliations

Exposure to selective serotonin reuptake inhibitors and the risk of congenital malformations: a nationwide cohort study

Espen Jimenez-Solem et al. BMJ Open. .

Erratum in

  • Correction.
    [No authors listed] [No authors listed] BMJ Open. 2013 Jan 24;3(1):e001148corr1. doi: 10.1136/bmjopen-2012-001148corr1. BMJ Open. 2013. PMID: 23355657 Free PMC article. No abstract available.

Abstract

Objectives: To analyse the relation between selective serotonin reuptake inhibitor (SSRI) use and major congenital malformations, with focus on malformations of the heart.

Design: Register-based retrospective nationwide cohort study, using the Danish Medical Birth Registry.

Setting: Denmark.

Participants: Pregnant women in Denmark between 1997 and 2009 and their offspring.

Primary outcome measures: For each SSRI, ORs for major congenital malformations were estimated using multivariable logistic regression models for women exposed to an SSRI during the first trimester and for women with paused exposure during pregnancy.

Results: The authors identified 848 786 pregnancies; 4183 were exposed to an SSRI throughout the first trimester and 806 pregnancies paused exposure during pregnancy. Risks of congenital malformations of the heart were similar for pregnancies exposed to an SSRI throughout the first trimester, adjusted OR 2.01 (95% CI 1.60 to 2.53), and for pregnancies with paused SSRI treatment during pregnancy, adjusted OR 1.85 (95% CI 1.07 to 3.20), p value for difference: 0.94. The authors found similar increased risks of specific congenital malformations of the heart for the individual SSRIs. Furthermore, the authors found no association with dosage.

Conclusions: The apparent association between SSRI use and congenital malformations of the heart may be confounded by indications. The moderate absolute risk increase combined with uncertainty for causality still requires the risk versus benefit to be evaluated in each individual case.

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Conflict of interest statement

Competing interests: All authors declare no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years; no other relationships or activities that could appear to have influenced the submitted work.

Figures

Figure 1
Figure 1
Rates per 1000 pregnancies of major congenital malformations for infants exposed to selective serotonin reuptake inhibitors in utero. Figure shows number of infants diagnosed with a major malformation per 1000 births. Rates are shown with 95% CIs.
See this image and copyright information in PMC

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