Selective serotonin reuptake inhibitors in pregnancy and congenital malformations: population based cohort study.
OBJECTIVE
To investigate any association between selective serotonin reuptake inhibitors (SSRIs) taken during pregnancy and congenital major malformations.


METHODS
Population based cohort study.


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


METHODS
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 low-for 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.


CONCLUSIONS
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.
Department of Epidemiology, Institute of Public Health, Aarhus University, Bartolin Allé 2, DK-8000 Aarhus, Denmark. LHP@dadlnet.dk
Lars Henning
LH
Pedersen
Tine Brink
TB
Henriksen
Mogens
M
Vestergaard
Jørn
J
Olsen
Bodil Hammer
BH
Bech
D000014:Abnormalities, Drug-Induced / Q000209:etiology*; D000928:Antidepressive Agents / Q000009:adverse effects*; D002648:Child; D015331:Cohort Studies; D003866:Depressive Disorder / Q000188:drug therapy*; D005260:Female; D006801:Humans; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects*
D000928:Antidepressive Agents; D017367:Selective Serotonin Reuptake Inhibitors