Ovalia Use In Pregnancy & Lactation

Women of perimenopausal status or child-bearing potential: Letrozole should only be used in women with a clearly established postmenopausal status. As there are reports of women regaining ovarian function during treatment with letrozole despite a clear postmenopausal status at start of therapy, the physician needs to discuss adequate contraception when necessary.
Pregnancy: Based on human experience in which there have been isolated cases of birth defects (labial fusion, ambiguous genitalia), letrozole may cause congenital malformations when administered during pregnancy. Studies in animals have shown reproductive toxicity.
Letrozole is contraindicated during pregnancy.
Lactation: It is unknown whether letrozole and its metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded.
Letrozole is contraindicated during breast-feeding.
Fertility: The pharmacological action of letrozole is to reduce oestrogen production by aromatase inhibition. In premenopausal women, the inhibition of oestrogen synthesis leads to feedback increases in gonadotropin (LH, FSH) levels. Increased FSH levels in tum stimulate follicular growth and can induce ovulation.