Ethinyl estradiol / segesterone Pregnancy and Breastfeeding Warnings

Brand names: Annovera

Medically reviewed by Drugs.com. Last updated on Oct 24, 2024.

Ethinyl estradiol / segesterone Pregnancy Warnings

Discontinue use if pregnancy occurs

US FDA pregnancy category: Not assigned

Risk Summary: Exposure to combined hormonal contraceptives before conception or during early pregnancy has not been associated with an increased risk of genital or nongenital birth defects.

Comments: This drug should be discontinued if pregnancy occurs as there is no reason for its use during pregnancy.

Animal studies have failed to reveal evidence of adverse developmental effects. Epidemiological data have failed to reveal an increased risk of birth defects following maternal exposure to low dose combined hormonal contraceptives prior to conception or during early pregnancy. There are no controlled data in human pregnancy.

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.

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Ethinyl estradiol / segesterone Breastfeeding Warnings

Not recommended

Excreted into human milk: Yes

Comments:
-Contraceptive hormones are present in human milk and can reduce milk production.

This combination hormonal contraceptive (CHC) system has not been specifically studied, however studies with segesterone implants have detected exposure to the breastfed infant.

Expert opinion recommends against use of combined hormonal contraceptives for the first 3 weeks postpartum due to increased risk for venous thromboembolism; women with other risk factors for venous thromboembolism should avoid use for 4 to 6 weeks after delivery. The World Health Organization guidelines recommend against use of combined oral contraceptives before 42 days postpartum and suggests that that the advantages of use between 6 weeks and 6 months postpartum is generally outweighed by risks.

See references

Further information

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