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Pregnancy: Femara is contraindicated during pregnancy (see CONTRAINDICATIONS).
There are been post-marketing reports of spontaneous abortions and congenital anomalies in infants of mothers who took Femara (see PRECAUTIONS) during pregnancy.
Isolated cases of birth defects (labial fusion, ambiguous genitalia) have been reported in infants born to pregnant women exposed to off label use (infertility treatment, ovulation induction) of Femara.
Lactation: Femara is contraindicated during lactation (see CONTRAINDICATIONS).
Females and males of reproductive potential: 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.
