Drospirenone / estetrol Pregnancy and Breastfeeding Warnings

Brand names: Nextstellis

Medically reviewed by Drugs.com. Last updated on Jun 7, 2023.

Drospirenone / estetrol Pregnancy Warnings

Use is not recommended.

AU TGA pregnancy category: B3
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 (including cardiac anomalies and limb-reduction defects) following exposure to combined oral contraceptives (COC) before conception or during early pregnancy.

Comments:
-Verify pregnancy status prior to administering this drug.
-Discontinue if pregnancy occurs since there is no reason for continued use.
-Placental transfer of estetrol, drospirenone, and/or their metabolites is expected.
-Consider increased risk of venous thromboembolism during the postpartum period when restarting this drug.

Animal studies revealed severe adverse effects on embryofetal development with the individual components of this combination drug. There are no controlled data in human pregnancy.

Embryofetal lethality was reported after oral administration of estetrol to pregnant rats and rabbits at doses yielding systemic exposure levels below or only marginally above the patients. Drospirenone, in combination with ethinylestradiol, also caused embryolethality. Drospirenone administered during the third trimester of pregnancy caused feminization of male fetuses in rats at dose levels that produced systemic exposure 8 to 13 times greater than what was clinically expected.

Last paragraphs:
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 / estetrol Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Yes

Comments:
-Inform postpartum females that this medication can decrease milk production.
-When possible, other methods of contraception should be used while breast-feeding.
-The WHO also advises against the use of COC in breastfeeding women 6 weeks to 6 months postpartum, as the risk of COCs does not outweigh the benefit.

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 the effect is likely dependent on dose and the 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 not use COCs during the fourth week postpartum because of potential effects on breastfeeding performance.

Women with other risk factors for venous thromboembolism should not use COCs for 4 to 6 weeks after delivery. WHO guidelines advise against the use of COCs for 6 months postpartum if breastfeeding.

See references

Further information

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