Is CCRIS 6525 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use CCRIS 6525? Is CCRIS 6525 safe for nursing mother and child? Does CCRIS 6525 extracts into breast milk? Does CCRIS 6525 has any long term or short term side effects on infants? Can CCRIS 6525 influence milk supply or can CCRIS 6525 decrease milk supply in lactating mothers?

Progestin containing contraceptive drug that is used as a single dose for oral, subcutaneous implant, intrauterine device (IUD), or emergency contraception administration.Also marketed in association with ethinylestradiol Levonorgestrel is a progestin, and active metabolite isomer of norgestrel, both derived from nortestosterone. It is excreted in breast milk in clinically non-significant amount, and, no problems have been observed in infants whose mothers were treated. The plasma levels of these infants were very low. Levonorgestrel and progestogens are generally considered contraceptive drugs of choice during lactation since they 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 CCRIS 6525 used alone. Those with an interest in a combination oral contraceptive should consult the record entitled, "Contraceptives, Oral, Combined." Although nonhormonal methods are preferred during breastfeeding, progestin-only contraceptives such as levonorgestrel are considered the hormonal contraceptives of choice during lactation. Fair quality evidence indicates that levonorgestrel 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.[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] After use of levonorgestrel as a postcoital contraceptive, nursing can resume 3 to 4 hours after the dose (or after each dose if the two-dose method is used). Postcoital levonorgestrel appears to have no long-term adverse effects on breastfeeding or the infant.[8][9][10][11]

One study found serum thyroid stimulating hormone levels to be lower in the infants exposed to levonorgestrel than in control infants.[18] A nonrandomized trial compared 250 breastfed infants whose mothers received 30 mcg daily of CCRIS 6525 initiated 7 days postpartum to 250 infants whose mothers received nonhormonal contraception. No differences in height and weight gain were seen during the 9-month study period between the 2 groups.[19] Multicenter, nonrandomized studies followed infants whose mothers received levonorgestrel contraception during breastfeeding, either as oral tablets of 37.5 mcg daily (n = 246) or as Norplant (n = 453). No adverse effects on infant growth through the first year were found in comparison to standard measurements.[20][21] In a cohort study of 71 women who took levonorgestrel as a postcoital contraceptive found no obvious decrease in milk supply after the drug was used according to maternal reports 75% of mothers re-initiated breastfeeding before 8 hours after the dose. None noticed any adverse effect in their infants.[8] In a cohort study, breastfed infants of women (n = 100) who used at least one dose of levonorgestrel as a postcoital contraceptive in addition to the lactational-amenorrhea method (LAM) of birth control were compared to infants whose mothers used LAM only (n = 100). No statistically significant differences were found between the groups in weight, length, head circumference, chest circumference, and mid-arm circumference at 3 and 6 months postpartum, nor in the Denver Developmental Screening Test results at 6 months postpartum.[11]

Among a cohort study of 71 women who took levonorgestrel as a postcoital contraceptive during nursing, none reported any obvious decrease in milk supply after the drug was used.[8] A study of 1158 postpartum randomized women using the lactational amenorrhea method (LAM) for birth control randomized to be given levonorgestrel as a postcoital contraceptive or given nothing. No difference in the duration of breastfeeding was found between women who used the levonorgestrel and those who did not.[9] 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 professed intrended 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 levonorgestrel, 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] In a cohort study, women (n = 100) who used at least one dose of levonorgestrel as a postcoital contraceptive in addition to the lactational-amenorrhea method (LAM) of birth control were compared to mothers used LAM only (n = 100). No difference was found in the mothers' subjective opinions of their milk supplies.[11]