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Drospirenone / estetrol Pregnancy and Breastfeeding Warnings

Medically reviewed by Drugs.com. Last updated on Jun 17, 2021.

Drospirenone / estetrol is also known as: Nextstellis

Drospirenone / estetrol Pregnancy Warnings

Use is not indicated

US FDA pregnancy category: Not assigned

Risk Summary: Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects following exposure to combined oral contraceptives (COC) before conception or during early pregnancy.

Comments:
-Discontinue if pregnancy occurs since there is no reason for continued use.
-Rule out pregnancy prior to initiating, especially in women with irregular menstrual cycles.
-Consider increased risk of venous thromboembolism during the postpartum period when restarting this drug.

Animal studies performed with estetrol have shown expected pharmacologic effects consistent with estrogen exposure. Epidemiologic studies and meta-analyses have not found an increased risk of birth defects including cardiac anomalies and limb-reduction defects following exposure to COCs before conception or 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.

See references

Drospirenone / estetrol Breastfeeding Warnings

Following oral ingestion of drospirenone 3 mg/ethinyl estradiol 30 mcg, about 0.02% of the drospirenone dose was measured in breast milk within 24 hours. Based on these results, the potential maximal dose a breastfed infant would receive is estimated to be less than 1 mcg/day. COCs might affect infant growth negatively during the first month of use. The magnitude of effect is likely dependent on dose and time COC was introduced postpartum. In the US, expert opinion advises women not to use COCs during the first 3 weeks after delivery because of concerns about increased risk for venous thromboembolism and to generally not use COCs during the fourth week postpartum because of potential effects on breastfeeding performance. Women with other risk factors for venous thromboembolism should generally not use COCs for 4 to 6 weeks after delivery. WHO guidelines advise against use of COCs for 6 months postpartum if breastfeeding.

Not recommended
-When possible, other methods of contraception should be used while breast-feeding

Excreted into human milk: Yes

Comments:
-Postpartum use of combined oral contraceptives (COC) is not recommend during the first 4 weeks after delivery due to increased risk for venous thromboembolism; women with other risk factors for venous thromboembolism should generally not use COC for 4 to 6 weeks after delivery.
-The World Health Organization (WHO) advises that COC not be used before 42 days postpartum; the WHO also advises against use of COC in breastfeeding women 6 weeks to 6 months postpartum, as the risk of COCs does not outweigh benefit.

See references

References for pregnancy information

  1. "Product Information. Nextstellis (drospirenone-estetrol)." Mayne Pharma, Greenville, NC.

References for breastfeeding information

  1. "Product Information. Nextstellis (drospirenone-estetrol)." Mayne Pharma, Greenville, NC.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.