Sertraline reaches very low levels in breast milk. In an observational study, the sertraline average level in breast milk was 45 mcg/L. Extrapolating these data, it is estimated that an infant exclusively breastfed may receive 0.5% of the weight-adjusted maternal dose. This same estimate was obtained in similar studies.
Usually sertraline can not be detected in the serum of infants exposed through breast milk, although it is frequently found a low concentration of the metabolite desmethylsertraline.
It have been reported two observations of adverse reactions in exposed infants. A case of benign myoclonus during sleep in an infant of four months of age and one case of agitation spontaneously resolved .
Although this medication can cause prolactin elevation, galactorrhea and gynecomastia in non-lactating women, does not seem to influence a woman with already established lactation.
For most experts, sertraline has one of the best safety profile antidepressants during breastfeeding, but if administered to a nursing mother, the baby should be monitored closely.
Warning of the manufacturer:
Isolated studies in a small number of women during lactation and their children showed the presence of negligible or undetectable amounts of sertraline in the serum of the child, although sertraline detected in breast milk was more concentrated that in maternal serum. This drug is not recommended for use in nursing women unless, in the opinion of the physician, the benefit outweighs the risk.
If using sertraline during pregnancy and/or breastfeeding, the doctor should know that during the marketing surveillance, in some infants whose mothers had been treated with SSRI antidepressants including sertraline,were observed certain symptoms, in addition to those associated with the withdrawal of medication.