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Increased risk of septal heart defects in newborns as a result of sertraline and citalopram intake during pregnancy

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Is there an association between selective serotonin reuptake inhibitors (SSRIs) taken during pregnancy and major congenital malformations?


493 113 children born between 1996 and 2003.


Population-based cohort study in Denmark using data from Danish registries (medical birth registry, national register of medicinal product statistics, fertility database and the national hospital register).

Risk factors:

Exposure to SSRIs during pregnancy; the exposure window was defined as 28 days before the beginning of gestation to 112 days after. Information on drug use was from nationwide registers on filled prescriptions.


Major malformations were categorised according to Eurocat (European Surveillance of Congenital Anomalies), with additional diagnostic grouping for heart defects. Information on outcomes was from delivery and hospital databases.



Retrospective cohort study.

Follow-up period:

To a maximum of 1 year after birth.

Main results

The filling of two or more prescriptions were not associated with major malformations (OR 1.21, 95% CI 0.91 to 1.62) or non-cardiac malformations (OR 1.12, …

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  • Sources of funding The Lundbeck Foundation, National Danish Research Foundation, The University of Aarhus, The Danish Society of Obstetrics and Gynaecology, The Ville Heise Foundation and the Rosalie Petersen Foundation.


  • Competing interests None.

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