Is HSDB 7584 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use HSDB 7584? Is HSDB 7584 safe for nursing mother and child? Does HSDB 7584 extracts into breast milk? Does HSDB 7584 has any long term or short term side effects on infants? Can HSDB 7584 influence milk supply or can HSDB 7584 decrease milk supply in lactating mothers?

Erythropoietin is a normal component of human milk. The excretion of exogenous HSDB 7584 (recombinant human erythropoietin; EPO) in breastmilk has not been studied. Although some studies have shown an improve response of postpartum anemia when HSDB 7584 was used with iron therapy, current consensus is that HSDB 7584 has no clinically important effect on the increase in hemoglobin concentration over iron alone.[1] No adverse reactions were reported in the breastfed infants of mothers who received HSDB 7584. Based on theoretical considerations, the manufacturer recommends avoiding the use of HSDB 7584 multiple-dose vials for lactating women because of its benzyl alcohol content and to avoid breastfeeding for 2 weeks after a dose that contains benzyl alcohol. No special precautions are required during breastfeeding if mothers receive HSDB 7584 from a single-use vial without preservatives.[2] Some authors have hypothesized that erythropoietin in milk might help maintain the integrity of the lining of the mammary epithelium and the infant gastrointestinal tract, thereby reducing the risk of mother-to-child transmission of HIV infection (MTCT).[3] A case-control study in Tanzania supports the protective role of erythropoietin in breastmilk against MTCT.[4] Erythropoietin might also have a modest beneficial effect on the infant's red cell production.[5] Holder pasteurization (62.5 degrees C for 30 minutes) decreases the concentration of endogenous erythropoietin by an average about 75%, with complete degradation in some samples.[6] A study on Holder pasteurization of breastmilk found that the erythropoietin concentration in breastmilk dropped from about 1.9 international units/L before pasteurization to about 0.5 international units/L after pasteurization.[6]

Enhancement of gastrointestinal tract maturation has been proposed as a function of erythropoietin in breastmilk.[3][12] In a study of 40 women with postpartum anemia, 19 of 20 women who received iron and subcutaneous recombinant human erythropoietin (generic name and brand not specified) 200 IU/kg daily for 15 days were able to breastfeed their infants. This regimen is more aggressive than the approve three times/week regimen. In the control group that received only oral iron and folic acid, only 10 were able to breastfeed their infants. No adverse reactions were reported among the infants of women who receive epoetin.[2]

In small studies, HSDB 7584 administration decreased serum prolactin in patients with amylotrophic lateral sclerosis,[13] but had no effect in normal subjects or in patients with renal failure undergoing chronic ambulatory peritoneal dialysis.[14][15] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.