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Ethinyl estradiol / levonorgestrel Pregnancy and Breastfeeding Warnings

Ethinyl estradiol / levonorgestrel is also known as: Alesse, Amethia, Amethyst, Ashlyna, Aubra, Aviane, Camrese, Chateal, Falmina, Introvale, Jolessa, Kurvelo, Larissia, Lessina, Levlen, Levora, Lillow, Lutera, Orsythia, Portia, Seasonale, Seasonique, Sronyx, Trivora, Vienva

Medically reviewed on Sep 14, 2018

Ethinyl estradiol / levonorgestrel Pregnancy Warnings

Use is contraindicated.

AU TGA pregnancy category: B3
US FDA pregnancy category: X

Comments:
-Rule out pregnancy prior to initiation.
-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.

Animal studies have not been reported. Epidemiological data have failed to reveal an increased risk of birth defects following maternal exposure to oral contraceptives prior to conception or when taken inadvertently 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 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.

See references

Ethinyl estradiol / levonorgestrel Breastfeeding Warnings

Jaundice and breast enlargement have been reported have been reported in the nursing infant when the mother was using oral contraceptives during breastfeeding. Combined oral contraceptives have also been known to reduce milk production and change the composition of breast milk.

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Yes

Comments:
-Women should avoid use of oral contraceptives and use other forms of 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 venous thromboembolism.
-Postpartum women who are breastfeeding with other risk factors for venous thromboembolism should not use combined hormonal contraceptives 4 to 6 weeks after delivery.
-Nursing mothers should not use combined hormonal contraceptives during the fourth week postpartum due to the potential to adversely affect the milk supply.
-The World Health Organization suggest that combined oral contraceptives should not be used in nursing mothers before 42 days postpartum and the disadvantages of using the method generally outweigh the advantages between 6 weeks and 6 months postpartum.

See references

References for pregnancy information

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

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. Alesse-28 (ethinyl estradiol-levonorgestrel)." Wyeth-Ayerst Canada Inc, St. Laurent, QC.
  4. "Product Information. Seasonale (ethinyl estradiol-levonorgestrel)." Barr Pharmaceuticals Inc, Pomona, NY.
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  6. Cerner Multum, Inc. "Australian Product Information." O 0
  7. "Product Information. Seasonique (ethinyl estradiol-levonorgestrel)." Teva Pharmaceuticals USA, North Wales, PA.
  8. 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 -]):
  9. "Product Information. Quartette (ethinyl estradiol-levonorgestrel)." Teva Pharmaceuticals USA, North Wales, PA.

Further information

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

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