Skip to Content

Ethinyl estradiol / ethynodiol Pregnancy and Breastfeeding Warnings

Ethinyl estradiol / ethynodiol is also known as: Demulen, Demulen 1/35, Demulen 1/50, Kelnor 1/35, Zovia, Zovia 1/35, Zovia 1/50

Ethinyl estradiol / ethynodiol Pregnancy Warnings

Oral contraceptive combinations have been assigned to pregnancy category X. 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. There is no indication for the use of oral contraceptive combinations during pregnancy. Oral contraceptive combinations are contraindicated for use during pregnancy.

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".

See references

Ethinyl estradiol / ethynodiol Breastfeeding Warnings

Both the estrogens and progestins occurring in commercially available oral contraceptive 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.

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 has not been associated with deleterious effects on breast-fed infants.

See references

References for pregnancy information

  1. Profumo R, Toce S, Kotagal S "Neonatal choreoathetosis following prenatal exposure to oral contraceptives." Pediatrics 86 (1990): 648-9
  2. Janerich DT, Piper JM, Glebatis DM "Hormones and limb-reduction deformities." Lancet 2 (1973): 96-7
  3. 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
  4. Bracken MB "Oral contraception and congenital malformations in offspring: a review and meta-analysis of the prospective studies." Obstet Gynecol 76 (1990): 552-7

References for breastfeeding information

  1. 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
  2. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  3. Canto TE, Vera L, Polanco LE, Colven CE "Mini-pill in lactating women." Contraception 39 (1989): 589-601
  4. Kacew S "Adverse effects of drugs and chemicals in breast milk on the nursing infant." J Clin Pharmacol 33 (1993): 213-21

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.