Is Norethindrone Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use Norethindrone? Is Norethindrone safe for nursing mother and child? Does Norethindrone extracts into breast milk? Does Norethindrone has any long term or short term side effects on infants? Can Norethindrone influence milk supply or can Norethindrone decrease milk supply in lactating mothers?

Progestin contraceptive used as a single product or linked to ethinyl estradiol (see Etinilestradiol + Norethindrone). Norethindrone is a progestin derivative of 19-nortestosterone. It is excreted in breast milk in clinically significant amount and no problems have been observed in infants whose mothers took it. Plasma levels of these infants were undetectable or very low. Progestin is generally considered contraceptive drugs of choice during lactation since it neither alter the quantity and composition of milk nor cause side effects on both growth of infants and the duration of breastfeeding.Published study results have shown protection against breast bone mass loss with the use of progestin-only contraceptives. For the first 6 weeks postpartum, non-hormonal methods are of choise. There is a debate on the role of progestin-related drugs in decreasing milk production when used before lactation has been fully established. The American Academy of Pediatrics states that this medication is usually compatible with breastfeeding.WHO List of Essential Medicines 2002: rates it as compatible with breastfeeding after the 6th postnatal week.

This record contains information specific to norethindrone used alone. Readers with an interest in a combination oral contraceptive should consult the record entitled, "Contraceptives, Oral, Combined." Poor to fair quality evidence indicates that norethindrone does not adversely affect the composition of milk, the growth and development of the infant or the milk supply.[1][2][3][4] Some evidence indicates that progestin-only contraceptives may offer protection against bone mineral density loss during lactation, or at least do not exacerbate it.[5][6][7] Although nonhormonal methods are preferred during breastfeeding, progestin-only contraceptives such as norethindrone are considered the hormonal contraceptives of choice during lactation. Fair quality evidence indicates that norethindrone does not adversely affect the composition of milk, the growth and development of the infant or the milk supply. Expert opinion holds that the risks of progestin-only contraceptive products usually are acceptable for nursing mothers at any time postpartum.[8][9]

No consistent physical, mental, or radiologic differences have been found in infants whose mothers were using norethindrone enanthate (Norplant).[13][14] Some studies found increased infant weight gain among the infants of treated women.[13][15][16] A non-blinded, randomized study of exclusively breastfeeding women compared those who received an etonogestrel implant 24-48 hours after delivery (n = 20) to those who received a 150 mg depot medroxyprogesterone acetate injection at 6 weeks postpartum (n = 20). Infants of the implant users gained more than the infants of the DMPA mothers during the first 6 weeks of life.[17] A short-term study of 12 women who received oral norethindrone 350 mcg daily starting 48 hours postpartum found no differences in infant weight gain over 14 days compared to 8 women taking a placebo.[18]

Studies of varying size and quality on the use of long-acting norethindrone injections (acetate or enanthate) have found that the use of levonorgestrel implants (Norplant or Norplant-2) as a contraceptive beginning at 6 weeks postpartum or later either has no clinically important negative effect on the quality of breastmilk and results in either no effect or an increase in the milk supply and duration of lactation [13][14][15][16] In one study, women who received the implant at 6 days postpartum, a transient decrease in milk protein occurred 2 weeks after implant insertion. A decrease in milk phosphorus content was also observed between 2 and 4 months after implant insertion in this group and at 3 months postpartum, the early insertion group had a higher rate of supplementation.[19] In another study, women given norethindrone enanthate depot injection less than 48 hours postpartum were 2.5 to 3 times more likely to have postpartum depression at 6 weeks postpartum. No differences were seen at 1 and 12 weeks postpartum.[20] A short-term study of 12 women who received oral norethindrone 350 mcg daily starting 48 hours postpartum found no differences in milk production or milk composition over 14 days compared to 8 women taking a placebo.[18] One small, nonrandomized study found that oral norethindrone 350 mcg daily decreased the quantity and quality (lower protein, lipids and calcium) compared to controls who received nonhormonal contraception.[21] In a nonrandomized, nonblinded study comparing women who were breastfeeding at discharge, 102 postpartum women received depot medroxyprogesterone acetate (dosage not stated) in the early postpartum period (average 51.9 hours postpartum; range 6.25 to 132 hours), 181 received another progestin-only contraceptive and 138 used nonhormonal contraception. No differences in breastfeeding rates were seen at 2 and 6 weeks, but women receiving any hormonal contraceptive were breastfeeding at a lower rate (72.1% vs 77.6%) at 4 weeks postpartum. The authors concluded that progestin-only contraception initiated in the early postpartum period had no adverse effects on breastfeeding rates.[22] A study analyzed data from a prospective cohort study of U.S. women from May 2005 through June 2007. Women were followed from the third trimester of pregnancy throughout the first year postpartum. Data from the subset of women who intended to breastfeed for 3 months or longer postpartum during their third trimester of pregnancy and who were using a contraceptive at 3 months postpartum were analyzed (n = 1349). Women who intended to breastfeed for at least 4 months and were taking a progestin-only oral contraceptive, such as norethindrone, were 3.15 times more likely to be breastfeeding (exclusive or nonexclusive) at 4 months than women who used a nonhormonal contraceptive. Women who said they would breastfeed for 3 to 4 months had 4-month breastfeeding rates equivalent to those using a nonhormonal contraceptive. These rates were much higher than those of women who were taking an estrogen-containing, combined oral contraceptive.[23]