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Levonorgestrel Pregnancy and Breastfeeding Warnings

Levonorgestrel is also known as: Aftera, Athentia Next, EContra EZ, Fallback Solo, Her Style, Liletta, Mirena, My Way, Next Choice, Next Choice One Dose, Norplant System, Opcicon One-Step, Option 2, Plan B, Plan B One-Step, Skyla

Levonorgestrel Pregnancy Warnings

Use is contraindicated. AU TGA pregnancy category: B3 US FDA pregnancy category: Not assigned. Risk Summary: There is an increased risk of miscarriage, sepsis, premature labor, and premature delivery if pregnancy occurs while using the intrauterine system. Comments: -This drug is intended to prevent pregnancy and should not be used in women who are already pregnant. -If pregnancy occurs while taking this drug, the patient should be apprised of the potential risks.

Animal studies have not been reported. The few studies of infant growth and development that have been conducted with progestin-only pills have failed to demonstrate significant adverse effects. 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 decision 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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Levonorgestrel Breastfeeding Warnings

Contraceptive use of this drug does not adversely affect the content or volume of breast milk nor the growth and development of the infant. Reports have demonstrated that approximately 0.1% of the maternal dose is transferred to the infant during breastfeeding, resulting in detectable steroid levels in infant plasma. However, there are no reports of adverse effects in infants breastfed by mothers taking progestin-only contraceptives. Isolated postmarketing cases of decreased milk production have been reported.

Use is considered acceptable. Excreted into human milk: Yes Comments: -This drug has been used without apparent harmful effects in the nursing infant. -When taken as a postcoital contraceptive, breastfeeding can resume 3 to 4 hours following each dose. -Uterine bleeding and perforation may be increased in lactating women using an intrauterine system.

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References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Liletta (levonorgestrel)." Actavis Pharma, Inc., Parsippany, NJ.
  3. "Product Information. Skyla (levonorgestrel)." Bayer Pharmaceutical Inc, West Haven, CT.
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. "Product Information. Mirena (levonorgestrel)." Berlex Laboratories, Richmond, CA.
  6. "Product Information. Plan B (levonorgestrel)." Women's Capital Corporation, Bellevue, WA.

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. "Product Information. Liletta (levonorgestrel)." Actavis Pharma, Inc., Parsippany, NJ.
  3. "Product Information. Mirena (levonorgestrel)." Berlex Laboratories, Richmond, CA.
  4. "Product Information. Skyla (levonorgestrel)." Bayer Pharmaceutical Inc, West Haven, CT.
  5. Cerner Multum, Inc. "Australian Product Information." O 0
  6. "Product Information. Plan B (levonorgestrel)." Women's Capital Corporation, Bellevue, WA.
  7. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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