Ethinyl estradiol / ethynodiol Pregnancy and Breastfeeding Warnings

Brand names: Demulen, Demulen 1/35, Demulen 1/50, Kelnor 1/35, Kelnor 1/50, Lo-Malmorede, Malmorede, Valtya 1/35, Valtya 1/50, Zovia 1/35, Zovia 1/35E, Zovia 1/50E

Medically reviewed by Drugs.com. Last updated on May 7, 2025.

Ethinyl estradiol / ethynodiol Pregnancy Warnings

Use is contraindicated.

US FDA pregnancy category: Not assigned.

Risk summary: There is no use for combined oral contraceptives (COC) in pregnancy. Inadvertent exposure to low-dose COCs during conception and early pregnancy did not show an increased risk of genital or non-genital birth defects.

Comments:
-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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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Ethinyl estradiol / ethynodiol Breastfeeding Warnings

Benefit should outweigh risk

Excreted into human milk: Yes

Comments:
-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.

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Further information

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