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Estradiol / norethindrone topical Pregnancy and Breastfeeding Warnings

Estradiol / norethindrone topical Pregnancy Warnings

Estradiol and norethindrone have been assigned to pregnancy category X by the FDA. Postmarketing human pregnancy data have revealed an association between estrogen therapy and an increased risk of vaginal adenosis, squamous cell dysplasia of the uterine cervix, and vaginal cancer development in female offspring and an increased risk of urogenital abnormalities and testicular cancer in male offspring. Furthermore, postmarketing human pregnancy data have revealed a possible association between first trimester progestin use and genitourinary anomalies in male and female fetuses. Estradiol-norethindrone topical is considered contraindicated during pregnancy.

Estradiol / norethindrone topical Breastfeeding Warnings

Estradiol and norethindrone are excreted into human milk in small amounts. Although adverse effects related to norethindrone in the nursing infant are unlikely, estrogens have been shown to decrease the quantity and quality of breast milk. The manufacturer recommends that caution be used when administering estradiol-norethindrone topical to nursing women.

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