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Dienogest / estradiol Pregnancy and Breastfeeding Warnings

Dienogest / estradiol is also known as: Natazia

Dienogest / estradiol Pregnancy Warnings

Use is contraindicated. AU TGA pregnancy category: B3 US FDA pregnancy category: Not assigned Comments: -Discontinue this drug if pregnancy occurs. -Consider the increased risk of venous thromboembolism when restarting this drug during the postpartum period. -Women who are not breastfeeding may start this drug no earlier than 4 weeks postpartum.

Animal studies do not indicate teratogenicity. There are no controlled data in human pregnancy. There is little or no increased risk of birth defects if this drug is inadvertently used during early pregnancy. Epidemiological studies and meta-analyses have not found an increased risk of genital or non-genital birth defects 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

Dienogest / estradiol Breastfeeding Warnings

Use is not recommended. Excreted into human milk: Yes Comments: -If possible, use of other forms of contraception until the child is weaned. -Estrogen containing combined oral contraceptives reduce milk production, which is less likely once breast feeding is well established, as well as change the composition of breast milk. -Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk, which may affect the child.

See references

References for pregnancy information

  1. "Product Information. Natazia (dienogest-estradiol)." Bayer Pharmaceutical Inc, West Haven, CT.
  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. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Natazia (dienogest-estradiol)." Bayer Pharmaceutical Inc, West Haven, CT.

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