Objective. Despite the manufacturer's recommendation that fluoxetine not be
used by women while breastfeeding, many women choose to do so. There is li
ttle information available in the literature to suggest that this practice
is or is not safe. The purpose of this study was to examine weight gain in
infants who are breastfed by mothers who take fluoxetine, compared with wei
ght gain in infants who are breastfed by mothers who do not take any psycho
therapeutic medication. A secondary goal was to assess the frequency of rep
orted side effects in infants who are breastfed by mothers who take fluoxet
ine.
Methodology. A retrospective cohort study design was used. Subjects were id
entified from an ongoing pregnancy outcome study conducted through the Cali
fornia Teratogen Information Service and Clinical Research Program. A total
of 64 women were interviewed who had taken fluoxetine during a pregnancy b
etween the 1989 and 1997; 26 of these women breastfed their infants and con
tinued to take the medication, and 38 breastfed their infants but did not t
ake the medication. Postnatal weight gain was taken from pediatric records,
and the frequency of side effects was measured by maternal response to the
interview questionnaire.
Results. Using linear regression analysis, the infants who were breastfed b
y mothers taking fluoxetine demonstrated a growth curve significantly below
that of infants who were breastfed by mothers who did not take the drug. T
he average deficit in measurements taken between 2 weeks and 6 months of ag
e was 392 g (95% confidence interval: -5, -780). Using a repeated measures
analysis of covariance for those infants with more than one postnatal weigh
t measurement available, the difference between the two groups was similar,
similar to 1.2 standard deviations (P = .005). In response to interview qu
estions regarding side effects, no mother who breastfed her infant while ta
king fluoxetine reported any unusual symptoms that could be attributed to t
he medication.
Conclusions. These data do not suggest that women who breastfeed while taki
ng fluoxetine are likely to note unusual behavior in their infants that the
y consider related to use of the medication. However, although there was no
excess of infants in the fluoxetine group with postnatal weight measuremen
ts >2 standard deviations below the mean, these data indicate that breastfe
eding while taking fluoxetine is associated with reduced growth that may be
of clinical importance in situations in which infant weight gain is alread
y of concern.