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Ethinyl estradiol / levonorgestrel Pregnancy and Breastfeeding Warnings

Ethinyl estradiol / levonorgestrel is also known as: Alesse, Altavera, Amethyst, Ashlyna, Aviane, Balcoltra, Camrese, Daysee, Jolessa, Kurvelo, Larissia, Lessina, Levora, LoSeasonique, Lutera, Marlissa, Orsythia, Seasonale, Seasonique, Setlakin, Simpesse, Sronyx, Triquilar 28, Twirla, Vienva

Medically reviewed by Drugs.com. Last updated on Jul 8, 2021.

Ethinyl estradiol / levonorgestrel Pregnancy Warnings

Contraindicated

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Risk Summary: There is no need for contraception once pregnancy occurs; epidemiologic studies have not shown an increased risk of birth defects with inadvertent maternal use of combined hormonal contraceptives during early pregnancy.

Comments:
-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 in infants born to mothers who have used oral contraceptives prior to pregnancy. Additionally, studies have not shown a teratogenic effect with inadvertent use 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 / levonorgestrel Breastfeeding Warnings

Combination hormonal contraceptives may affect the composition of breastmilk; however, evidence suggests in healthy, well-nourished mothers, this is not likely. Combined hormonal contraceptives might transiently negatively affect growth during the first month but are unlikely to adversely affect long-term infant growth and development. The effect on lactation largely depends on time of introduction of the combined hormonal contraceptive postpartum and the dose. 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. Introduction of an estrogen before 3 weeks postpartum may increase the risk of thromboembolism in postpartum women. Rare cases of reversible breast enlargement in breastfed infants have been reported, mostly with estrogen doses higher than those currently used.

Expert opinion in the United States recommends postpartum breastfeeding women avoid combined hormonal contraceptives during the first 3 weeks after delivery because of concerns about the increased risk for venous thromboembolism; during the fourth week postpartum, combined hormonal contraceptives should be avoided because of concerns on breastfeeding performance. Postpartum breastfeeding women with other risk factors for venous thromboembolism generally should not use combined hormonal contraceptives 4 to 6 weeks after delivery. The World Health Organization (WHO) guidelines are more restrictive, advising that combined hormonal contraceptives be avoided in breastfeeding mothers before 42 days postpartum. The WHO guidelines assess the risks of use as greater than the benefits between 6 weeks and 6 months postpartum.

Not recommended

Excreted into human milk: Yes

Comments:
-Breastfeeding women should be advised to use another method of contraception until discontinuing breastfeeding.
-Contraceptive hormones can reduce milk production in breastfeeding women; this reduction can occur at any time but is less likely to occur once breastfeeding is well established.

See references

References for pregnancy information

  1. "Product Information. Triphasil (ethinyl estradiol-levonorgestrel)." Wyeth-Ayerst Laboratories, Philadelphia, PA.
  2. "Product Information. LoSeasonique (ethinyl estradiol-levonorgestrel)." Teva Pharmaceuticals USA, North Wales, PA.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Alesse-28 (ethinyl estradiol-levonorgestrel)." Wyeth-Ayerst Canada Inc, St. Laurent, QC.
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  6. "Product Information. Twirla (ethinyl estradiol-levonorgestrel)." Agile Therapeutics, Inc., Princeton, NJ.
  7. "Product Information. Seasonale (ethinyl estradiol-levonorgestrel)." Barr Pharmaceuticals Inc, Pomona, NY.
  8. "Product Information. Quartette (ethinyl estradiol-levonorgestrel)." Teva Pharmaceuticals USA, North Wales, PA.
  9. "Product Information. Seasonique (ethinyl estradiol-levonorgestrel)." Teva Pharmaceuticals USA, North Wales, PA.

References for breastfeeding information

  1. "Product Information. LoSeasonique (ethinyl estradiol-levonorgestrel)." Teva Pharmaceuticals USA, North Wales, PA.
  2. "Product Information. Triphasil (ethinyl estradiol-levonorgestrel)." Wyeth-Ayerst Laboratories, Philadelphia, PA.
  3. "Product Information. Twirla (ethinyl estradiol-levonorgestrel)." Agile Therapeutics, Inc., Princeton, NJ.
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  5. "Product Information. Seasonique (ethinyl estradiol-levonorgestrel)." Teva Pharmaceuticals USA, North Wales, PA.
  6. 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 -]):
  7. Cerner Multum, Inc. "Australian Product Information." O 0
  8. "Product Information. Quartette (ethinyl estradiol-levonorgestrel)." Teva Pharmaceuticals USA, North Wales, PA.
  9. "Product Information. Alesse-28 (ethinyl estradiol-levonorgestrel)." Wyeth-Ayerst Canada Inc, St. Laurent, QC.
  10. "Product Information. Seasonale (ethinyl estradiol-levonorgestrel)." Barr Pharmaceuticals Inc, Pomona, NY.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.