Cyproterone Acetate and Ethinylestradiol Pills During Breastfeeding

Direct Recommendation

Combined oral contraceptives containing cyproterone acetate and ethinylestradiol should be avoided during breastfeeding, particularly in the first 6 months postpartum, due to risks of reduced milk production and potential infant exposure to hormones. 1, 2, 3

Evidence-Based Rationale

Combined Hormonal Contraceptives Are Not Recommended

The Centers for Disease Control and Prevention explicitly states that combined hormonal contraceptives (containing estrogen) should not be used during breastfeeding, especially in the first 6 months postpartum. 1

Combined oral contraceptives are classified as U.S. MEC Category 4 (absolutely contraindicated) in the first 3 weeks postpartum due to increased venous thromboembolism risk 1
From 4 weeks to 6 months postpartum, they are U.S. MEC Category 3 (generally should not be used) due to potential negative effects on breastfeeding performance 1
Estrogen-containing contraceptives can reduce milk production in breastfeeding women, and this reduction can occur at any time but is less likely once breastfeeding is well-established 2, 3

Specific Concerns with Cyproterone Acetate/Ethinylestradiol

The World Health Organization recommends avoiding breastfeeding if possible when using ethinylestradiol-containing contraceptives, as infant risk cannot be ruled out 4

Research demonstrates that cyproterone acetate transfers into breast milk at measurable concentrations:

Plasma-to-milk ratio varies between 0.6 and 9.3, with a mean of 2.8 5
Approximately 0.2% of the maternal dose (range: 0.06-0.41%) would be transferred to the nursing infant 5
A 2 mg dose of cyproterone acetate (as in combination pills) would result in approximately 1 microgram/kg transfer to the infant 5

FDA Labeling Guidance

The FDA-approved labeling for ethinylestradiol-containing contraceptives explicitly states that contraceptive hormones and/or metabolites are present in human milk and can reduce milk production. 2, 3

The developmental and health benefits of breastfeeding should be considered, but mothers should be advised to use other contraceptive methods until discontinuing breastfeeding 2
When possible, nursing females should use alternative contraception methods 2

Clinical Algorithm for Decision-Making

If Contraception Is Needed During Breastfeeding:

First-line option: Progestin-only pills (POPs)
- Can be started immediately postpartum 1
- No backup contraception needed if started within 6 months postpartum while amenorrheic and fully/nearly fully breastfeeding (≥85% of feeds) 1
- If started >21 days postpartum without return of menses, use backup contraception for 7 days 1
Avoid combined hormonal contraceptives entirely during the first 6 months 1
If a woman insists on combined hormonal contraceptives:
- Wait a minimum of 6 weeks postpartum 1
- Ensure no additional VTE risk factors are present 1
- Confirm access to supplemental milk 1
- Strongly counsel about milk production risks 2, 3

Common Pitfalls to Avoid:

Do not assume that medications safe in pregnancy are safe during breastfeeding - the nursing infant has different vulnerabilities than the fetus 6
Do not prescribe combined hormonal contraceptives in the early postpartum period - the VTE risk is substantially elevated in the first 3 weeks 1
Do not overlook the impact on milk supply - even after 6 weeks, estrogen can reduce milk production at any time 2

Alternative Safer Options

For women requiring hormonal contraception while breastfeeding, progestin-only methods are strongly preferred:

Progestin-only pills are the safest oral contraceptive option for breastfeeding mothers 1
Other progestin-only methods (implants, intrauterine devices) are also compatible with breastfeeding 1

For acne treatment specifically (if this is the indication):

Consider non-hormonal alternatives during the breastfeeding period 4
Topical therapies may be preferable to minimize systemic exposure 6

Are cyproterone acetate and ethinylestradiol (EE) pills safe to use during breastfeeding?

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