Raloxifene Pregnancy and Breastfeeding Warnings

Raloxifene is also known as: Evista

Raloxifene Pregnancy Warnings

In rat studies, decreased fetal development and developmental abnormalities (wavy ribs, kidney cavitation) occurred at doses greater than or equal to 0.2 times the human dose based on body surface area. Treatment of rats at gestation with doses ranging from 0.2 to 1.6 times the human dose resulted in delayed and disrupted parturition, decreased neonatal survival, altered physical development, sex- and age-specific reduction in growth and changes in pituitary hormone content and decreased lymphoid compartment size in offspring. At 10 mg/kg, raloxifene resulted in maternal and progeny morbidity and death. Effects in adult rats at four months of age revealed uterine hypoplasia and reduced fertility but no ovarian or vaginal pathology was observed.

Raloxifene has been assigned to pregnancy category X by the FDA. Animal studies have revealed evidence of abortion, fetal heart anomalies, hydrocephaly, retardation of fetal development and survival, and changes in pituitary hormone content. There are no controlled data in human pregnancy. Raloxifene use is considered contraindicated during pregnancy or in any woman planning to become pregnant.

Raloxifene Breastfeeding Warnings

There are no data on the excretion of raloxifene into human milk. Raloxifene is considered contraindicated during breast-feeding by the manufacturer.

Treatment of lactating rats with doses ranging from 0.02 to 1.6 times the human dose resulted in delayed and disrupted parturition, decreased neonatal survival, altered physical development, sex- and age-specific reductions in growth and changes in pituitary hormone content and decreased lymphoid compartment size in offspring.

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