Olanza 10 Use In Pregnancy & Lactation

Fertility: The mating performance, but not the fertility, of male rats was impaired during administration of Olanzapine at doses that were 11 times the maximum recommended human daily dose (MRHD) of 20 mg per day on mg per square meter of body surface area (mg/m²). The impairment of mating performance was reversed with discontinuation of Olanzapine administration. Studies in female rats indicate that Olanzapine may produce a delay in ovulation. When Olanzapine was administered at doses that were 1.5 times the MRHD on a mg/m² basis, female rats showed a decrease in fertility. At doses that were 2.5 times the MRHD on a mg/m² basis, female rats showed an increased precoital period, and a reduced mating index.
Pregnancy: Adequate and well-controlled studies in humans have not been done.
Of seven pregnancies that occurred during clinical trials with Olanzapine, two resulted in normal births, one resulted in neonatal death due to a cardiovascular defect, three ended in therapeutic abortions, and one ended in spontaneous abortion.
Olanzapine crosses placenta in rats. No evidence of teratogenicity was seen in rats administered Olanzapine at doses up to nine times the MRHD on a mg/m² basis, or in rabbits administered Olanzapine at doses up to 30 times the MRHD on a mg/m² basis. At the maximum doses in these studies, early fetal resorptions and increased numbers of nonviable fetuses were observed in rats, and increased fetal resorptions and decreased fetal weight were observed in rabbits. The maximum dose used in the rabbit study was considered to be maternally toxic. Also, in rats, gestation was prolonged at a dose that was five times the MRHD on a mg/m² basis. FDA Pregnancy Category C.
Breast-feeding: It is not known whether Olanzapine is distributed into human breast milk. However, Olanzapine is distributed into the milk of rats, and use in nursing mothers is not recommended.