title: Sertraline use during pregnancy and the risk of major malformations.
abstract: OBJECTIVE
  Given the current debate and growing public concerns on selective serotonin reuptake inhibitors (SSRIs) and birth defects generated by Food and Drug Administration warnings, we aim to quantify the association between first-trimester exposure to sertraline, a first-line treatment, and the risk of congenital malformations in a cohort of depressed women.
  
  
  METHODS
  This was a population-based cohort study in Quebec, Canada, 1998 through 2010. From a cohort of 18,493 depressed/anxious pregnancies, sertraline-exposed, nonsertraline SSRI-exposed, non-SSRI exposed, and unexposed (reference category) women were studied. Major malformations overall and organ-specific malformations in the first year of life were identified. Generalized estimating equation models were used to obtain risk estimates and 95% confidence intervals (CIs). Analyses were adjusted for potential confounders.
  
  
  RESULTS
  Among the 18,493 eligible pregnancies, 366 were exposed to sertraline, 1963 to other SSRIs, and 1296 to non-SSRI antidepressants during the first trimester of pregnancy. Sertraline use was not statistically significantly associated with the risk of overall major malformations when compared to nonuse of antidepressants. However, sertraline exposure was associated with an increased risk of atrial/ventricular defects specifically (risk ratio [RR], 1.34; 95% CI, 1.02-1.76; 9 exposed cases), and craniosynostosis (RR, 2.03; 95% CI, 1.09-3.75; 3 exposed cases). Exposure to SSRIs other than sertraline during the first trimester of pregnancy was associated with craniosynostosis (RR, 2.43; 95% CI, 1.44-4.11; 19 exposed cases), and musculoskeletal defects (RR, 1.28; 95% CI, 1.03-1.58; 104 exposed cases).
  
  
  CONCLUSIONS
  Sertraline use during the first trimester of pregnancy was associated with an increased risk of atrial/ventricular defects and craniosynostosis above and beyond the effect of maternal depression. Nonsertraline SSRIs were associated with an increased risk of craniosynostosis and musculoskeletal defects.
authors: Research Center, Sainte-Justine Hospital, and Faculty of Pharmacy, University of Montreal, Montreal, Quebec, Canada. Electronic address: anick.berard@umontreal.ca.
authors: Anick
authors: A
authors: Bérard
authors: Research Center, Sainte-Justine Hospital, and Faculty of Pharmacy, University of Montreal, Montreal, Quebec, Canada.
authors: Jin-Ping
authors: JP
authors: Zhao
authors: Research Center, Sainte-Justine Hospital, Montreal, Quebec, Canada.
authors: Odile
authors: O
authors: Sheehy
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000453:epidemiology* / Q000209:etiology*; D000328:Adult; D000928:Antidepressive Agents / Q000009:adverse effects*; D015331:Cohort Studies; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D018570:Risk Assessment; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects*; D020280:Sertraline / Q000009:adverse effects*
chemical_list: D000928:Antidepressive Agents; D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline
keywords: cardiac defect; craniosynostosis; major congenital malformations; pregnancy; selective serotonin reuptake inhibitor; sertraline