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Selective serotonin reuptake inhibitors in pregnancy and congenital malformations: population based cohort study

Lars Henning Pedersen1, Tine Brink Henriksen, Mogens Vestergaard

  • 1Department of Epidemiology, Institute of Public Health, Aarhus University, Bartolin Allé 2, DK-8000 Aarhus, Denmark. LHP@dadlnet.dk

BMJ (Clinical Research Ed.)
|September 25, 2009
PubMed

Insights

Selective serotonin reuptake inhibitors (SSRIs) during pregnancy were not linked to major malformations overall. However, SSRI use, especially sertraline and citalopram, showed an increased prevalence of septal heart defects in newborns.

Area of Science:

  • Perinatal medicine
  • Pharmacovigilance
  • Congenital anomaly research

Background:

  • Selective serotonin reuptake inhibitors (SSRIs) are commonly prescribed for depression.
  • Concerns exist regarding potential risks of SSRI exposure during pregnancy.

Purpose of the Study:

  • To examine the association between prenatal SSRI use and congenital major malformations.
  • To identify specific SSRIs or patterns of use associated with increased risk.

Main Methods:

  • Population-based cohort study of 493,113 children born in Denmark (1996-2003).
  • Utilized nationwide registers for prescription data, delivery, and diagnoses.
  • Major malformations classified using Eurocat, with detailed analysis of heart defects.

Main Results:

  • No overall association between SSRIs and major malformations.
  • Increased prevalence of septal heart defects observed with SSRI use (OR 1.99).
  • Sertraline (OR 3.25) and citalopram (OR 2.52) showed significant associations with septal heart defects. Use of multiple SSRIs increased risk (OR 4.70).

Conclusions:

  • Prenatal SSRI exposure, particularly sertraline and citalopram, is associated with an increased prevalence of septal heart defects.
  • Prescription of multiple SSRIs during early pregnancy showed the strongest association with septal heart defects.
  • The absolute increase in malformation prevalence remains low, but warrants attention.
Abstract

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