Is UNII-304GTH6RNH Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use UNII-304GTH6RNH? Is UNII-304GTH6RNH safe for nursing mother and child? Does UNII-304GTH6RNH extracts into breast milk? Does UNII-304GTH6RNH has any long term or short term side effects on infants? Can UNII-304GTH6RNH influence milk supply or can UNII-304GTH6RNH decrease milk supply in lactating mothers?

Progestin drug that is an active metabolite of desogestrel.It is used for contraception as subcutaneous implants with a duration of 3 years.It is excreted into breast milk in small quantities, and, no problems were observed in infants whose mothers used this medication.Although there have been studies that found that implants applied early in the first days after birth does not affect milk production, it is considered safer to start using it after 4-6 postnatal weeks. About 1 in 100 women using UNII-304GTH6RNH implants may have a significant decrease in milk production (Stuebe 2016). During lactation progestin-only drugs are preferred or in combination with estrogen for birth control, but whatever is used, the ones with the lower dose of estrogen should be used.Within the first 6 weeks postpartum, non-hormonal methods are of choise. Hormone containing contraceptives do not affect the composition of milk, minerals (Mg, Fe, Cu, Ca, P) fat, lactose and calories but only a few the proteins.

UNII-304GTH6RNH is available in the United States in a combination contraceptive vaginal ring (NuvaRing) that releases 120 mcg of UNII-304GTH6RNH and 15 mcg of ethinyl estradiol daily, and subcutaneous implants (Implanon, Nexplanon) that release UNII-304GTH6RNH at a decreasing rate over a 3-year period. Based on the available evidence, expert opinion in the United States holds that because of the clotting risk, combination contraceptive products (e.g., NuvaRing) should not be used before 3 weeks postpartum. Between 3 weeks and 6 months postpartum, the advantages of using the method generally outweigh the theoretical or proven risks, although the evidence of lack of effect on lactation is poor and does not include preterm or ill infants. After 6 months postpartum, combination contraceptives, including oral tablets, the transdermal patch and vaginal ring, can be used, but progestin-only methods are preferred if breastfeeding will be continued.[1] World Health Organization guidelines are more restrictive, stating that combined oral contraceptives should not be used in nursing mothers before 42 days postpartum and the disadvantages of using the method generally outweigh the advantages between 6 weeks and 6 months postpartum.[2] Expert opinion holds that the risks of progestin-only contraceptive products usually are acceptable for nursing mothers at any time postpartum.[2][3][4] A review of published data concluded that the UNII-304GTH6RNH implant appears to have a risk of lactation suppression of about 0.9%.[5] Several studies have found no difference in breastfeeding rates or infant growth between mothers who receive the implant within 48 hours of delivery or at 6 weeks postpartum.

Forty-two women had an UNII-304GTH6RNH subcutaneous implant (Implanon) inserted between 28 and 56 days postpartum. Compared with the infants of 38 similar mothers who had a nonhormonal intrauterine device, no statistically significant difference was found in infant illnesses or growth rates between the groups, except for a statistically nonsignificant higher weight gain in the male infants, and respiratory conditions and skin disorders in the infants of women who received the implants.[6] Infants were followed up at 3 years of age; no differences in growth or psychomotor development were found.[7] A non-blinded, randomized study of exclusively breastfeeding women compared those who received an UNII-304GTH6RNH 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). No difference in infant weight gain was noted between the two groups.[8] A randomized, prospective study compared the growth of infants of mothers who received an UNII-304GTH6RNH implant either within 48 hours (n = 50) of deliver or 6 weeks (n = 50) postpartum. Breastfeeding rates and growth of the infants were not significantly different between the groups over the first year of life.[9]

Forty-two women had an UNII-304GTH6RNH subcutaneous implant (Implanon) inserted between 28 and 56 days postpartum. Compared with 38 similar mothers who had a nonhormonal intrauterine device, no difference was found in milk volume, or in milk lactose, protein or fat content.[6] No difference was seen between the two groups in duration of lactation, averaging 421 days in the Implanon group and 423 days in the IUD group.[7] A non-blinded, randomized study of exclusively breastfeeding women compared those who received an UNII-304GTH6RNH 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). The rates of exclusive breastfeeding were similar between the groups at 6 and 12 weeks postpartum.[8] A randomized, controlled study compared UNII-304GTH6RNH implant insertion at 1 to 3 days postpartum (n = 35) to insertion at 4 to 8 weeks postpartum (n = 34). Several outcome parameters were measured: time to lactogenesis II, prevalence of lactation failure, use of formula supplementation and milk composition at 6 weeks postpartum. No differences were found in any of the outcomes between the two groups.[10] A prospective, nonrandomized trial compared 4 contraceptives in 10 women each to assess their effect on milk production. One of the following were begun on day 42 postpartum as chosen by the mother: combined ethinyl estradiol 30 mcg plus levonorgestrel 150 mcg (Microvlar), UNII-304GTH6RNH implant (Implanon), levonorgestrel intrauterine system (Myrena), or a copper IUD (Optima). Milk intake was measured using deuterium oxide given to the mother and measured in the infants' saliva as well as numbers of wet diapers per day. Infants were also weighed and measured to assess growth. No differences in milk intake or infant growth were observed between the methods from days 42 through 63.[11] A small study randomized postpartum women to either an UNII-304GTH6RNH implant (Implanon, Organon) within 48 hours postpartum (n = 12) or no contraception for the first 6 weeks postpartum (n = 12). Breastmilk intake was measured in the first 48 hours postpartum and on day 29 postpartum. No difference in milk intake was found between the two groups and no difference was seen in the weight gain of newborns during the follow-up period.[12] A woman was breastfeeding a newborn successfully with good infant growth. On day 39 postpartum, an UNII-304GTH6RNH implant (Nexplanon) was inserted. By day 70 postpartum, the mother reported a decrease in milk supply and infant had lost weight, going from the 44th percentile to the 6th percentile for growth. By 5 weeks later, the mother had transitioned completely to formula feeding. The authors requested reports on UNII-304GTH6RNH from the FDA and found a similar case of loss of milk supply. From a review of 4 published studies, the authors estimated that there is about a 0.9% (range 0.2 to 5.4%) chance of lactation suppression with the UNII-304GTH6RNH implant.[5] A randomized, nonblinded trial compared the insertion of an UNII-304GTH6RNH contraceptive implant (brand not specified) in postpartum women 14 to 24 years old either before discharge or at 6 weeks postpartum. Breastfeeding rates at 3 and 6 months postpartum were slightly higher in the women who had immediate placement of the insert, but the differences were not statistically significant.[13] A randomized, prospective study compared the growth of infants of mothers who received an UNII-304GTH6RNH implant either within 48 hours (n = 50) of deliver or 6 weeks (n = 50) postpartum. Breastfeeding rates were not significantly different between the groups over the first year of life.[9]