Ethinyl estradiol / ethynodiol Pregnancy and Breastfeeding Warnings
Medically reviewed by Drugs.com. Last updated on Jul 8, 2022.
Ethinyl estradiol / ethynodiol is also known as: Demulen, Demulen 1/35, Demulen 1/50, Kelnor 1/35, Kelnor 1/50, Lo-Malmorede, Malmorede, Zovia 1/35, Zovia 1/35E, Zovia 1/50E
Ethinyl estradiol / ethynodiol Pregnancy Warnings
Use is contraindicated.
US FDA pregnancy category: X
-This drug is intended to prevent pregnancy and should not be used in women who are already pregnant or suspect they may be pregnant.
-Discontinue use if pregnancy is confirmed.
-Avoid administration to induce withdrawal bleeding as a test for pregnancy.
-Avoid administration during pregnancy to treat threatened or habitual abortion.
Extensive epidemiological data have failed to reveal an increased risk of birth defects following maternal use of oral contraceptives prior to conception or when taken inadvertently during early pregnancy. There are no controlled data in human pregnancy.
US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
Ethinyl estradiol / ethynodiol Breastfeeding Warnings
Benefit should outweigh risk
Excreted into human milk: Yes
-Whenever possible, women should be advised that non-estrogen containing contraception should be avoided until their child is completely weaned.
-Ethinyl estradiol in doses greater than 30 mcg/day can suppress lactation and lead to more supplementation and possibly earlier discontinuation of breastfeeding than nonhormonal or progestin-only contraception.
It is important to weigh the increased risk of VTE during the postpartum period when considering contraceptive choices; most experts consider progestin-only contraception acceptable for nursing mothers at any time postpartum. The clotting risk of combination contraceptive products (including this product) preclude its use before 3 weeks postpartum. Experts in the US believe the advantages of combined hormonal contraceptives generally outweigh the theoretical or proven risks between 3 weeks and 6 months postpartum; however, evidence is poor for its effect on lactation, especially for preterm or ill infants. Estrogens may reduce the quantity and change the composition of breast milk. Guidance from the World Health Association advises against combined oral contraceptives in nursing mothers before 42 days postpartum and further suggests the disadvantages of using combined oral contraceptives generally outweigh the advantages between 6 weeks and 6 months postpartum.
References for pregnancy information
- Bracken MB "Oral contraception and congenital malformations in offspring: a review and meta-analysis of the prospective studies." Obstet Gynecol 76 (1990): 552-7
- Profumo R, Toce S, Kotagal S "Neonatal choreoathetosis following prenatal exposure to oral contraceptives." Pediatrics 86 (1990): 648-9
- Janerich DT, Piper JM, Glebatis DM "Hormones and limb-reduction deformities." Lancet 2 (1973): 96-7
- Czeizel AE, Kodaj I "A changing pattern in the association of oral contraceptives and the different groups of congenital limb deficiencies." Contraception 51 (1995): 19-24
References for breastfeeding information
- Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
- McCann MF, Moggia AV, Higgins JE, Potts M, Becker C "The effects of a progestin-only oral contraceptive (levonorgestrel 0.03 mg) on breast-feeding." Contraception 40 (1989): 635-48
- Canto TE, Vera L, Polanco LE, Colven CE "Mini-pill in lactating women." Contraception 39 (1989): 589-601
- Kacew S "Adverse effects of drugs and chemicals in breast milk on the nursing infant." J Clin Pharmacol 33 (1993): 213-21
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.