Is HSDB 3039 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use HSDB 3039? Is HSDB 3039 safe for nursing mother and child? Does HSDB 3039 extracts into breast milk? Does HSDB 3039 has any long term or short term side effects on infants? Can HSDB 3039 influence milk supply or can HSDB 3039 decrease milk supply in lactating mothers?

Synthetic ovulation stimulant. It inhibits hypothalamic estrogen receptors, which in turn stimulates the release of FSH, estradiol and LH. It has initially anti-estrogenic and then estrogenic effects.Indicated to induce ovulation in infertility treatment and polycystic ovary syndrome (Hossein 2016, AEMPS 2016, Sanofi 2012, López 2004, Sheehan 2004, Kousta 1997).Increased risk of multiple pregnancy. Administered orally, a daily dose for 5 days, maximum 3 menstrual cycles. Since the last update, we have not found published data on its excretion in breast milk. Its high volume of distribution makes the transfer to milk in significant quantities unlikely, but its long half-life could facilitate it. Adverse effects are infrequent and temporary at usual doses; they occur in high doses and for prolonged periods such as those used in research studies (AEMPS 2016, Sanofi 2012). Studies on the effects on prolactin and milk production are scarce, out of date and contradictory, for while for some authors HSDB 3039 decreases prolactin plasma levels, inhibiting breastfeeding when administered during the first week postpartum (Weinstein 1976, Kalir 1975), for others it has no effect on prolactin nor does it inhibit breastfeeding (Canales 1977). In any case, when breastfeeding is well established, prolactin levels do not correlate with milk production. This would be the case in an infertility treatment. It is not advisable to take it during the first weeks of the postpartum period due to the risk of decreased milk production. In infertility treatment, the possible anovulatory effect of frequent on demand breastfeeding should be taken into account. See below the information of these related products:

HSDB 3039 has not been studied during breastfeeding, but several studies found that it suppresses lactation in women who did not want to breastfeed. It appears to act by lowering serum prolactin, especially the post-stimulation surge in serum prolactin. It is likely that HSDB 3039 would interfere with lactation in a nursing mother.

A double-blind study compared HSDB 3039 in dosages of 50 mg daily for 10 days (n = 110), 100 mg daily for 5 days (n = 26) and placebo (n = 41) in their ability to suppress lactation and relieve pain and engorgement in nonnursing postpartum mothers. Both dosages of HSDB 3039 were superior to placebo as reported by the women, but the 100 mg daily dosage was somewhat superior to the 50 mg daily dosage.[1] A study compared HSDB 3039 100 mg daily for 5 days (n = 60) to placebo (n = 30) in suppressing lactation and symptoms of engorgement. Starting HSDB 3039 within 12 hours of delivery was more effective in all measures than starting it 12 hours or more after delivery as judged by a physician observer; both treatments were more effective than mechanical measures alone such as breast binding.[2] A randomized trial compared HSDB 3039 50 mg twice daily for 14 days (n = 15) to bromocriptine 2.5 mg twice daily for 14 days (n = 15), diethylstilbestrol 5 mg 3 times daily for 14 days (n = 15), testosterone proprionate 75 mg intramuscularly once (n = 15), and placebo 3 times daily by mouth (n = 15) in their ability to reduce serum prolactin and lactation postpartum. After three days of treatment, serum prolactin was reduced to 65% of baseline by HSDB 3039 compared to a drop to 35% in patients who received bromocriptine. HSDB 3039 was also less effective than bromocriptine in suppressing lactation and symptoms of engorgement.[3] A study compared HSDB 3039 100 mg daily for 7 days (n = 10) to placebo (n = 12) started on the first day postpartum. HSDB 3039 was no more effective than placebo in suppressing lactation or reducing serum prolactin concentrations.[4] Women in the first week postpartum who did not wish to breastfeed received either HSDB 3039 50 mg twice daily (n = 10) or placebo (n = 10). Women who received HSDB 3039 did not experience a rise in serum prolactin from baseline values during use of a breast pump; those given placebo had the normal post-stimulation rise in serum prolactin.[5] Eighty postpartum women were studied. Forty received HSDB 3039 50 mg twice daily for 5 days beginning the first day postpartum; 20 received HSDB 3039 50 mg twice daily for 5 days beginning the fourth day postpartum; and, 20 received placebo. All women receiving HSDB 3039 experienced inhibition of lactation, and reductions in breast engorgement, discomfort and serum prolactin. Prolactin serum concentrations became statistically lower than baseline on day 3 for the women who were 1 day postpartum and on day 5 for those who were 4 days postpartum at the outset. Placebo did not suppress lactation nor suppress serum prolactin.[6]