Norethindrone Pregnancy and Breastfeeding Warnings
Norethindrone Pregnancy Warnings
Several reports have suggested the risk of hypospadias in the general population, approximately 5 to 8 per 1000 male births, may double with progestin exposure within the first four months of pregnancy. Although there are insufficient data to quantify the risk to exposed female fetuses, progestin use within the first trimester has been associated with mild virilization of the external genitalia.
Norethindrone has been assigned to pregnancy category X by the FDA. Animal studies have not been reported. Postmarketing human pregnancy data have revealed a possible association between first trimester progestin use and genitourinary anomalies in male and female fetuses. Norethindrone use is considered contraindicated during pregnancy.
Norethindrone Breastfeeding Warnings
Progestin excretion into human milk results in steroid levels in infant plasma of 1% to 6% of the levels of maternal plasma. Long-term follow-up studies have failed to document adverse developmental effects due to exposure to progestins in breast milk.
Progestins are excreted into human milk in small amounts. The effects in the nursing infant are unknown. Progestins, such as progesterone, are considered compatible with breast-feeding by the American Academy of Pediatrics.
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