Drospirenone / ethinyl estradiol / levomefolate calcium Pregnancy and Breastfeeding Warnings

Brand names: Beyaz, Rajani, Safyral, Tydemy

Medically reviewed by Drugs.com. Last updated on Sep 4, 2023.

Drospirenone / ethinyl estradiol / levomefolate calcium Pregnancy Warnings

Use is contraindicated

US FDA pregnancy category: Not assigned

Risk Summary: There is no need for contraception once pregnancy occurs; epidemiologic studies and meta-analysis have not shown an increased risk of birth defects with inadvertent exposure to low dose combined oral contraceptives prior to conception or during early pregnancy.

Comments:
-This drug is contraindicated in pregnancy because there is no indication for use; discontinue promptly if pregnancy occurs.
-Women who do not breastfeed may start combined oral contraceptives no sooner than 4 weeks postpartum.

Epidemiological studies have not shown increased birth defects when combined oral contraceptives are used prior to pregnancy, or increased teratogenicity when inadvertently taken during early pregnancy. This drug should be started no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week. 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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Drospirenone / ethinyl estradiol / levomefolate calcium Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Yes

Comments:
-Combined oral contraceptives may reduce mild production; when possible, women should be advised to use other forms of contraception until she has weaned her child.

Estrogen-containing oral contraceptives can reduce milk production in nursing mothers; this is less likely to occur once breastfeeding is well established, however, it can occur at any time. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk; one study showed about 0.02% of drospirenone 3 mg/ethinyl estradiol 0.3 mg dose excreted into breastmilk in 24 hours. Folate has not been found to have an adverse effect on nursing infants.

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Further information

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