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

Jimenez-Solem E, Andersen JT, Petersen M, Broedbaek K, Jensen JK, Afzal S, Gislason GH, Torp-Pedersen C, Poulsen HE - BMJ Open (2012)

Bottom Line: Denmark.Furthermore, the authors found no association with dosage.The moderate absolute risk increase combined with uncertainty for causality still requires the risk versus benefit to be evaluated in each individual case.

View Article: PubMed Central - PubMed

Affiliation: Laboratory of Clinical Pharmacology, Rigshospitalet, Copenhagen, Denmark.

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.

No MeSH data available.


Related in: MedlinePlus

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.
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fig1: 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.

Mentions: The rate of major congenital malformations among pregnancies exposed to any SSRI throughout the first trimester was 50 per 1000 pregnancies compared with 35 per 1000 unexposed pregnancies (figure 1). We found an association between SSRI exposure and major congenital malformations, adjusted OR 1.33 (95% CI 1.16 to 1.53) (table 2).


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

Jimenez-Solem E, Andersen JT, Petersen M, Broedbaek K, Jensen JK, Afzal S, Gislason GH, Torp-Pedersen C, Poulsen HE - BMJ Open (2012)

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.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC3378942&req=5

fig1: 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.
Mentions: The rate of major congenital malformations among pregnancies exposed to any SSRI throughout the first trimester was 50 per 1000 pregnancies compared with 35 per 1000 unexposed pregnancies (figure 1). We found an association between SSRI exposure and major congenital malformations, adjusted OR 1.33 (95% CI 1.16 to 1.53) (table 2).

Bottom Line: Denmark.Furthermore, the authors found no association with dosage.The moderate absolute risk increase combined with uncertainty for causality still requires the risk versus benefit to be evaluated in each individual case.

View Article: PubMed Central - PubMed

Affiliation: Laboratory of Clinical Pharmacology, Rigshospitalet, Copenhagen, Denmark.

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.

No MeSH data available.


Related in: MedlinePlus