P.1.048 Effects of first-trimester fluoxetine exposure on the newborn

Prenatal Antidepressant Exposure: Clinical and Preclinical Findings

“…The extant literature indicates that congenital malformations are not associated with prenatal exposure to TCAs or SRIs (McElhatton et al, 1996;Ericson et al, 1999;Djulus et al, 2006;Lennestål and Källén, 2007), SRIs alone (Pastuszak et al, 1993;Goldstein et al, 1997;Kulin et al, 1998b;Simon et al, 2002;Hendrick et al, 2003a;Yaris et al, 2004;Malm et al, 2005;Sivojelezova et al, 2005;Källén and Otterblad Olausson, 2007;Pedersen et al, 2009), or atypical antidepressants (Einarson et al, 2003;Yaris et al, 2004;Chun-Fai-Chan et al, 2005). A meta-analysis of first trimester exposure to several classes of antidepressant confirmed these observations .…”

Fetal Effects of Selective Serotonin Reuptake Inhibitor Treatment During Pregnancy: Immediate and Longer Term Child Outcomes

“…Both of these studies represent updates on previous publications with smaller cohorts, that failed to demonstrate an association 30,60 . Once the earlier publications from the Swedish and Finnish Birth Registries are removed from consideration, five cohort studies failed to report an association 36,38,44,67,71 which was consistent with the negative findings from the case control studies by Pedersen et al and Alwan et al 58,65 . A significant relationship between fluoxetine exposure and specific malformations has been reported in four studies 58,63,69,72 , three of which reported a significant association with cardiac defects 63,69,72 , with the fourth, a case control study, reporting an increased risk of craniosynostosis 58 .…”

Prenatally Diagnosed Ectrodactyly at 16 Weeks’ Gestation by 2- and 3-Dimensional Ultrasonography

“…A summary of almost 800 fluoxetineexposed pregnancies reported to the manufacturer described rates of early pregnancy loss and congenital abnormalities similar to those of controls [10] . Furthermore, fluoxetine has not been reported to cause malformation in animals or humans.…”