Is Norethindrone (progestin) 0.35 mg daily a good option for a breastfeeding mother?

Norethindrone 0.35 mg Daily for Breastfeeding Mothers

Norethindrone 0.35 mg daily (progestin-only pill) can be used during breastfeeding and may be started immediately postpartum, but should be used with caution in women with a history of gestational diabetes, particularly in Latino populations, due to a two- to threefold increased risk of developing type 2 diabetes. 1

Timing and Initiation

• Progestin-only pills (POPs) can be started at any time postpartum, including immediately after delivery, if it is reasonably certain the woman is not pregnant 1
• The U.S. Medical Eligibility Criteria rates POPs as category 2 (advantages generally outweigh risks) if started <1 month postpartum and category 1 (no restrictions) if started ≥1 month postpartum in breastfeeding women 1
• No back-up contraception is needed if the woman is <6 months postpartum, amenorrheic, and fully or nearly fully breastfeeding (≥85% of feeds are breastfeeds) 1
• If started ≥21 days postpartum without meeting the above criteria, the woman needs to abstain from intercourse or use additional contraception for 2 days 1

Critical Safety Consideration: Diabetes Risk

The most significant concern is the increased diabetes risk in specific populations:

• In Latino breastfeeding women with prior gestational diabetes mellitus (GDM), progestin-only oral contraceptives at 0.35 mg/day norethindrone were associated with a two- to threefold increase in diabetes risk 1
• This same increased risk was observed with long-acting injectable depo medroxyprogesterone acetate (150 mg every 3 months) 1
• Progestin-only agents should therefore be used with caution during breastfeeding, particularly in women with prior GDM 1

Alternative Considerations

• Non-hormonal contraceptive methods can be prescribed using standard guidelines and avoid the diabetes risk entirely 1
• Combination oral contraceptives containing the lowest estrogen doses can be started 6-8 weeks after delivery if the woman is breastfeeding, though these carry different risk profiles 1
• For women with prior GDM, pregnancy planning should include evaluation of glucose tolerance before discontinuing contraception 1

Contraceptive Effectiveness

• The 0.35 mg norethindrone dose has demonstrated a drug-effectiveness rate of 1.9 pregnancies per 100 woman-years and a use-effectiveness rate of 2.5 per 100 woman-years with continuous daily administration 2
• Consistent daily timing is essential for effectiveness, as POPs have a narrower window for efficacy compared to combination pills 1

Clinical Algorithm for Decision-Making

For breastfeeding women requesting norethindrone 0.35 mg:

1. Screen for history of gestational diabetes mellitus

   • If GDM history present AND patient is Latino: strongly consider non-hormonal methods first due to 2-3x diabetes risk 1
   • If GDM history present in any population: counsel about diabetes risk and consider glucose tolerance testing before initiation 1

2. If no GDM history or patient accepts diabetes risk after counseling:

   • Can initiate immediately postpartum or at any time during breastfeeding 1
   • Ensure patient understands importance of daily dosing at same time
   • Provide back-up contraception instructions based on timing of initiation 1

3. Ongoing monitoring:

   • Women with prior GDM should have oral glucose tolerance testing repeated at 1 year and at minimum every 3 years thereafter 1
   • Blood pressure monitoring at each visit 3
   • Annual clinical review for stable patients 3

Important Caveats

• Do not confuse norethindrone 0.35 mg (progestin-only pill for contraception) with norethindrone 1 mg (used for endometrial protection with estrogen replacement) - these are different indications and doses 4
• The diabetes risk data specifically applies to the 0.35 mg daily contraceptive dose in breastfeeding women with prior GDM 1
• Pregnancy is an absolute contraindication (Category X) before initiating therapy 3