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Drospirenone / ethinyl estradiol Pregnancy and Breastfeeding Warnings

Drospirenone / ethinyl estradiol is also known as: Gianvi, Loryna, Nikki, Ocella, Syeda, Vestura, Yaela, Yasmin, Yaz, Zarah

Drospirenone / ethinyl estradiol Pregnancy Warnings

Use is contraindicated. (AU, US) Use is not indicated. (UK) AU TGA pregnancy category: B3 US FDA pregnancy category: Not assigned Comments: -Rule out pregnancy prior to starting this medication. -Discontinue this drug immediately if pregnancy occurs. -There is little or no increased risk of birth defects when combined oral contraceptives are inadvertently used during early pregnancy. -Administration to induce withdrawal bleeding should not be used as a test for pregnancy. -Do not use during pregnancy to treat threatened or habitual abortion. -Women who do not breastfeed should start oral contraceptives no earlier than 4 weeks postpartum. -Consider the increased risk of venous thromboembolism during the postpartum period when restarting this drug.

Animal studies showed drospirenone crossing the placenta and entering the fetus with oral administration. A dose dependent increase in embryolethality due to pre- and post-implantation losses was seen in animals. Dose dependent feminization of male fetuses and virilization of female fetuses was seen with a combination of predrospirenone and ethynylestradiol in the last third of pregnancy; effects on males were seen at 8 to 13 times the human dose; effects on females were seen at 2 to 5 times the human dose. There are no controlled data in human pregnancy. Epidemiological studies have not shown increased birth defects with combined oral contraceptive use prior to pregnancy, or increased teratogenicity when inadvertently taken during 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 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

Drospirenone / ethinyl estradiol Breastfeeding Warnings

Use is not recommended. Excreted into human milk: Yes Comments: -Combined oral contraceptives may reduce the quantity and change the composition of breast milk. -Small amounts (about 0.02%) of the drugs and/or their metabolites are excreted in breast milk and may affect the child. -Use is not recommended until the child has been completely weaned. -Advise use of other contraceptive methods until the child has been weaned.

See references

References for pregnancy information

  1. "Product Information. Gianvi (drospirenone-ethinyl estradiol)." Teva Pharmaceuticals USA, North Wales, PA.
  2. "Product Information. Yasmin (drospirenone-ethinyl estradiol)" Berlex Laboratories, Richmond, CA.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Gianvi (drospirenone-ethinyl estradiol)." Teva Pharmaceuticals USA, North Wales, PA.
  2. "Product Information. Yasmin (drospirenone-ethinyl estradiol)" Berlex Laboratories, Richmond, CA.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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