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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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Question

Question:

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

People:

493 113 children born between 1996 and 2003.

Setting:

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.

Outcomes:

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.

Methods

Design:

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 …

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