The use of psychotropic medications during lactation has not been inve
stigated in a controlled and systematic fashion. The literature is lad
en with case reports and small case series containing numerous confoun
ds that render the establishment of definitive treatment guidelines te
nuous. The increasing number of women who plan to breast-feed and the
high rate of psychiatric illness during the postpartum period undersco
re the need to develop such guidelines. A MEDLINE search was conducted
for key words either in the titles or abstracts of publications citin
g the use of psychotropic medications in lactating women and describin
g the pharmacokinetics of medication excretion into boast milk. The pu
blications identified span over three decades. The largest single stud
y by one group of investigators examined 12 mother-infant pairs. The m
ajority of studies report their results as a ratio of the breast milk
concentration to the maternal serum concentration (milk/plasma [M/P])
ratio. Estimations that use the M/P ratio of the infant daily dose ran
ge from 0.1% to 6.2% of the maternal dose. Few studies attempt to acco
unt for the complex variations in the maternal, breast milk, and infan
t physiologic environments. The major confounds of the studies reviewe
d include (I) failure to document portion of breast milk assayed (fore
milk versus hindmilk), (2) limited metabolite assay, (3) limited assay
sensitivity (1-25 ng/mL), not of research quality, (4) concomitant ma
ternal and/or infant medications, and (5) medication exposure during p
regnancy. Despite these confounds, there are remarkably few reports of
adverse effects on nursing infants exposed to psychotropic medication
s in breast milk. The limited data confirm that psychotropic medicatio
ns are excreted into breast milk and that the infant is exposed to the
se medications. The ideal breast milk study that accounts for the conf
ounds identified has not been completed. The complex matrix of breast
milk and the changing infant metabolic capacity will require a more de
tailed analysis with assays of improved sensitivity. Despite the limit
ed reports of adverse effects on nursing infants, the limitations of t
he available literature and minimal sample sizes make it premature to
recommend specific medications from a given class. There is inadequate
data on nursing infant exposure to multiple medications to support ch
anging medication to a different agent in an otherwise stable patient.
An individualized risk/benefit assessment with the empirical goal of
minimizing infant exposure while maintaining maternal emotional health
is the ideal approach.