Ethinyl estradiol/norethindrone Pregnancy and Breast Feeding Warnings

Ethinyl estradiol/norethindrone is also known as: Aranelle, Balziva, Brevicon, Estrostep Fe, Femcon Fe, femhrt, Genora 0.5/35, Genora 1/35, Gildess FE 1.5/0.03, Gildess FE 1/0.2, Jenest, Junel 1.5/30, Junel 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Loestrin 1/20, Loestrin 21 1.5/30, Loestrin 21 1/20, Loestrin 24 Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin 1/20, Microgestin Fe 1.5/30, Microgestin Fe 1/20, Modicon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Nelova 0.5/35, Nelova 1/35, Nelova 10/11, Norethin 1/35 E, Norinyl 1/35, Norinyl 1+35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 10/11, Ortho-Novum 7/7/7, Ovcon 35, Ovcon 35 Fe, Ovcon 50, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent

Overview

Do not use Norethindrone/Ethinyl Estradiol if you are pregnant. If you think you may be pregnant, contact your doctor right away. Norethindrone/Ethinyl Estradiol is found in breast milk. Do not breast-feed while taking Norethindrone/Ethinyl Estradiol .

Ethinyl estradiol/norethindrone Pregnancy Warnings

Ethinyl estradiol-norethindrone has been assigned to pregnancy category X by the FDA. Animal studies have failed to reveal evidence of teratogenicity. Ethinyl estradiol-norethindrone is considered contraindicated during pregnancy.

Although some reports have suggested that oral contraceptive hormones may cause a variety of congenital malformations, recent studies (including a meta-analysis of prospective studies) have suggested that an association between oral contraceptive use and congenital malformations does not exist. Some progestins may cause masculinization of female infants. One case report has suggested that oral contraceptive hormones may cause choreoathetosis in infants exposed in utero. A recent case control study has suggested a weak association between use of older high dose contraceptives (particularly those containing 1.0 mg of ethynodiol diacetate) and the occurrence of congenital limb defects. However, the authors concluded that "this weak causal relationship was probable in the past when relatively high doses of contraceptive pills were used. This risk is apparently minimized by the use of new type (e.g., D-norgestrel) and lower dose of contraceptive pills".

Ethinyl estradiol/norethindrone Lactation Warnings

Both the estrogens and progestins occurring in commercially available oral formulations are excreted into human milk in very small amounts. The American Academy of Pediatrics considers use of oral contraceptive combinations to be compatible with breast-feeding despite rare reports of breast enlargement in the nursing infant and the possibility of a decrease in milk production and protein content. The manufacturer recommends that caution be used when administering ethinyl estradiol-norethindrone to nursing mothers.

Some studies have examined the effect of progestin-only contraceptives on breast-feeding. The extent to which such studies have bearing on oral contraceptive combinations is uncertain. Use of such formulations have not been associated with deleterious effects on breast-fed infants.

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