First-Trimester Use of Selective Serotonin-Reuptake Inhibitors and the Risk of Birth Defects

Antidepressant Use in Pregnancy and the Risk for Cardiac Defects

“…4 In 2005, based on early results of two epidemiologic studies, the US Food and Drug Administration (FDA) warned healthcare professionals that early prenatal exposure to paroxetine may increase the risk of congenital cardiac malformations and reclassified it to pregnancy category D. 5 Most malformations in the early reports leading to the FDA warning were septal defects. Since then, several studies have evaluated the teratogenicity of SSRIs and other antidepressants [6][7][8][9][10][11][12][13][14][15][16][17][18][19] , but considerable controversy remains as to whether this is a "serious concern or much ado about little" as noted in an editorial published with two of the reports. 13,1420 Existing studies have reported different associations, often in the context of multiple comparisons.…”

“…Since then, several studies have evaluated the teratogenicity of SSRIs and other antidepressants [6][7][8][9][10][11][12][13][14][15][16][17][18][19] , but considerable controversy remains as to whether this is a "serious concern or much ado about little" as noted in an editorial published with two of the reports. 13,1420 Existing studies have reported different associations, often in the context of multiple comparisons. Yet, at least two studies reported a 2-3 fold increased risk of right ventricular outflow tract obstruction defects associated with paroxetine use 13,14 , and of ventricular septal defects associated with sertraline use.…”

“…13,1420 Existing studies have reported different associations, often in the context of multiple comparisons. Yet, at least two studies reported a 2-3 fold increased risk of right ventricular outflow tract obstruction defects associated with paroxetine use 13,14 , and of ventricular septal defects associated with sertraline use. 13,19 A meta-analysis estimated a 50% increased prevalence of cardiac defects overall with first trimester paroxetine use.…”

Association between reported venlafaxine use in early pregnancy and birth defects, national birth defects prevention study, 1997–2007

“…A previous analysis of data from the National Birth Defects Prevention Study (NBDPS) showed associations between SSRIs and anencephaly, craniosynostosis, and omphalocele (Alwan et al, 2007). A similar study by Louik et al (2007) found associations between individual SSRIs and certain birth defects, such as sertraline and septal heart defects, sertraline and omphalocele, and paroxetine and RVOTO defects. Although SSRIs and SNRIs might function similarly to treat depressive symptoms, much less is known about the risk of SNRIs (such as venlafaxine) and their use during pregnancy.…”

“…Some suggest that SSRIs might be associated with an increased risk of heart defects, mainly septal defects and right ventricular outflow tract obstruction (RVOTO) defects (Källén, 2004a;Bar-Oz et al, 2007;Bérard et al, 2007;Cole et al, 2007;Ferreira et al, 2007;Källén and Otterblad Olausson, 2007;Louik et al, 2007;Diav-Citrin et al, 2008;Einarson et al, 2008). A previous analysis of data from the National Birth Defects Prevention Study (NBDPS) showed associations between SSRIs and anencephaly, craniosynostosis, and omphalocele (Alwan et al, 2007).…”