We explore the effects on the developing fetus and neonate of selectiv
e serotonin-reuptake inhibitors (SSRIs) during pregnancy and lactation
, reviewing the relevant animal and human studies published in English
from 1976 to the present. Medline was used to search the terms SSRI,
fluoxetine, pregnancy, lactation, and teratogenesis. Animal studies we
re inconclusive: some found that fetal exposure to high doses of fluox
etine produced no congenital anomalies, while others linked the drug t
o abnormalities such as craniofacial malformations, alterations in ser
otonergic neurotransmitter systems, birth-related hematomas, and inhib
ition of the milk-ejection reflex. Human investigations indicated no r
elationship between in utero exposure to fluoxetine and teratogenic ef
fects, although data are limited, and none have been collected regardi
ng behavioral teratogenesis. However, we found a suggestion of an incr
eased rate of miscarriage, an association with infants large for gesta
tional age, one reported case of perinatal toxicity, and one case of a
n infant who was colicky while receiving breast milk from a mother tak
ing fluoxetine. Based on these data, controlled prospective studies of
exposure to SSRIs during pregnancy and lactation are needed, as is lo
ng-term evaluation for behavioral teratogenesis and enduring cognitive
effects. Data are lacking on drug levels in breast milk and neonatal
serum. Neonatal toxicity and the effect of SSRIs on labor and delivery
, the mother-infant interaction, and lactation also merit further stud
y. Clinically, a conservative approach is encouraged, minimizing the u
se of SSRIs in pregnancy, avoiding such drugs during the first trimest
er, tapering them prior to delivery, and discouraging breast-feeding d
uring their use.