Fluoxetine and its effects on the nursing infant: A prospective cohort study

Fluoxetine is a medication frequently used by women in their childbearing years. To date, only one study has systematically investigated the effects of this agent on the infant when used by a breastfeeding mother. The purpose of this study was to estimate the risk of adverse effects in infants breastfed by mothers receiving fluoxetine and to determine if the drug has an effect on infant weight gain. A total of 51 women who took fluoxetine post partum, were included as the exposed group and 63 women in the control group. The exposed and control groups were similar in terms of maternal age, parity, alcohol consumption, smoking habits, gestational age at delivery, birth weight and infant age at follow-up. Almost 60% of the mothers in the exposed group commenced drug therapy after delivery. The mean maternal dose of fluoxetine was 26 mg/d (range: 10-80 mg/d). There were 6 (11.8%) mothers in the exposed group, and 2 (3.2%) mothers in the control group, who reported adverse events in their children (p=0.13), which resolved spontaneously. Two additional cases in the exposed group had adverse events at birth suggestive of withdrawal. Infant's birth weight percentile, follow-up weight percentile and change in weight was not significantly different between the two groups (p=0.51). The results of this study indicate that fluoxetine use during lactation does not appear to present a major risk to the breastfed infant in terms of clinical adverse events or infant weight gain.