Safe use of fluoxetine during pregnancy and lactation has not been established. Therefore it should not be administered to women of childbearing potential or nursing mothers unless, in the opinion of the treating physician, the expected benefits to the patient outweigh the possible hazards to the child or fetus. In 1 breast milk sample, the concentration of fluoxetine plus norfluoxetine was 70.4 ng/ml. The concentration in the mother's plasma as 295.0 ng/mL. No adverse effects on the infant were reported.