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Women of child-bearing potential (and contraceptive measures, if applicable): There have been post-marketing reports of spontaneous abortions and congenital anomalies in infants of mothers who have taken Letrozole (see Precautions). The physician needs to discuss the necessity of adequate contraception with women who have the potential to become pregnant including women who are perimenopausal or who recently became postmenopausal, until their postmenopausal status is fully established (see Pharmacology: Toxicology: Non-clinical safety data under Actions).
Pregnancy: Letrozole is contraindicated during pregnancy and lactation (see Contraindications).
Isolated cases of birth defects (labial fusion, ambiguous genitalia) have been reported in pregnant women exposed to Letrozole (see Pharmacology: Toxicology: Non-clinical safety data under Actions).
Breast-feeding: Letrozole is contraindicated during lactation (see Contraindications).
