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Estradiol / norethindrone Pregnancy and Breastfeeding Warnings

Estradiol / norethindrone is also known as: Activella, CombiPatch, Ena, Mimvey, Mimvey Lo

Estradiol / norethindrone 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 is considered contraindicated during pregnancy.

Estradiol / norethindrone Breastfeeding Warnings

Estradiol and progestins are excreted into human milk in small amounts. Estrogens have been shown to decrease the quantity and quality of breast milk. The manufacturer recommends that caution be used when administering estradiol-norethindrone to nursing women.

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