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Desogestrel / ethinyl estradiol Pregnancy and Breastfeeding Warnings

Desogestrel / ethinyl estradiol is also known as: Apri, Azurette, Bekyree, Caziant, Cesia, Cyclessa, Cyred, Desogen, Emoquette, Enskyce, Isibloom, Juleber, Kalliga, Kariva, Kimidess, Mircette, Ortho-Cept, Pimtrea, Reclipsen, Simliya, Solia, Velivet, Viorele, Volnea

Desogestrel / ethinyl estradiol Pregnancy Warnings

Use is contraindicated. AU TGA pregnancy category: B3 US FDA pregnancy category: X Comments: -Women of childbearing potential should be advised to avoid becoming pregnant while receiving this medication. -Patients who become pregnant should discontinue this drug.

Animal studies of estrogen at high doses have revealed evidence of urogenital malformations. There are no controlled data for either drug in human pregnancy. Epidemiological data have failed to reveal an increased risk of birth defects when this drug was taken before pregnancy, and teratogenicity when patients inadvertently used this drug in early 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

Desogestrel / ethinyl estradiol Breastfeeding Warnings

Use during lactation may decrease the quality and quantity of breastmilk.

Breastfeeding is not recommended during use of this drug. Excreted into human milk: Yes Comments: -Patients should avoid use until the infant has been weaned. -Some experts recommend using nonhormonal forms of contraception during breastfeeding; in breastfeeding patients, progestin-only contraceptives are preferred over combined contraceptive drugs, especially up to 4 weeks postpartum. -Neonatal jaundice and breast enlargement have been reported in patients who received oral contraceptives.

See references

References for pregnancy information

  1. "Product Information. Cyclessa (desogestrel-ethinyl estradiol)" Organon, West Orange, NJ.
  2. "Product Information. Ortho-Cept (desogestrel-ethinyl estradiol)." Ortho Pharmaceutical Corporation, Raritan, NJ.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. 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. "Product Information. Ortho-Cept (desogestrel-ethinyl estradiol)." Ortho Pharmaceutical Corporation, Raritan, NJ.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  5. "Product Information. Cyclessa (desogestrel-ethinyl estradiol)" Organon, West Orange, NJ.

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