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Ethinyl estradiol / etonogestrel Pregnancy and Breastfeeding Warnings

Ethinyl estradiol / etonogestrel is also known as: NuvaRing

Ethinyl estradiol / etonogestrel Pregnancy Warnings

Use is contraindicated. AU TGA pregnancy category: B3 US FDA pregnancy category: Not assigned. Risk Summary: No increased risk of genital or non-genital birth defects observed following maternal exposure prior to conception or during early pregnancy. 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.

Animal studies have failed to reveal evidence of adverse developmental effects. Epidemiological data have failed to reveal an increased risk of birth defects following maternal exposure to low dose combined hormonal contraceptives prior to conception or during early pregnancy. There are no controlled data in human pregnancy. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. 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.

See references

Ethinyl estradiol / etonogestrel Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug. Excreted into human milk: Yes Comments: -Women should use non-estrogen containing contraception until the child is completely weaned. -Postpartum women who are breastfeeding should not use combined hormonal contraceptives during the first 3 weeks after delivery due increased risk for thromboembolism. -Between 3 weeks and 6 months postpartum, the advantages of using the method generally outweigh the theoretical or proven risks, although the evidence of lack of effect on lactation is poor and does not include preterm or ill infants. -After 6 months postpartum, combination contraceptives, including the vaginal ring, can be used, but progestin-only methods are preferred if breastfeeding will be continued. -Expert opinion recommends that the risks of progestin-only contraceptives are acceptable for nursing mothers at any time postpartum.

Combined hormonal contraceptives may reduce milk production in breastfeeding mothers.

See references

References for pregnancy information

  1. "Product Information. NuvaRing (ethinyl estradiol-etonogestrel)." Organon, West Orange, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. NuvaRing (ethinyl estradiol-etonogestrel)." Organon, West Orange, NJ.
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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