Escitalopram Pregnancy and Breastfeeding Warnings

Escitalopram is also known as: Lexapro

Escitalopram Pregnancy Warnings

Escitalopram has been assigned to pregnancy category C by the FDA. Escitalopram is the S-enantiomer of racemic citalopram. Human spontaneous abortion has been reported by the manufacturer of citalopram. Animal studies have revealed evidence of adverse effects on embryo/fetal and postnatal development, including teratogenic effects, when administered at doses greater than human therapeutic doses. There are no controlled data in human pregnancy. Escitalopram should be given during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

Escitalopram Breastfeeding Warnings

In one case, the infant was reported to have recovered completely upon discontinuation of citalopram by the mother. In the second case, no follow up information is available.

Racemic citalopram is excreted into human milk. There have been two reports of infants experiencing excess somnolence, decreased feeding, and weight loss in association with breast-feeding from a citalopram- treated mother. The decision to continue or discontinue either nursing or escitalopram therapy should take into account both the risks of escitalopram exposure to the infant and the benefits of escitalopram therapy for the mother. The results of two case reports and a small study appear to indicate that escitalopram has a low potential for causing adverse effects in breastfed infants. In the study, mothers (n=8) received a median escitalopram dose of 10 mg daily (range 10 to 20 mg). At steady state, the mean milk/plasma ratio for escitalopram and demethylescitalopram were both 2.2 and the absolute infant doses were 7.6 mcg/kg/day and 3.0 mcg/kg/day, respectively. The overall mean relative infant dose for escitalopram and demethylescitalopram was 5.3% of the weight- adjusted maternal dose. Compared with maternal plasma levels, plasma levels of parent drug and metabolite in the infants tested were low or below the limit of detection. Assessment of all of the breastfed infants (i.e., case reports and study) revealed no adverse effects.

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