Is HSDB 3311 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use HSDB 3311? Is HSDB 3311 safe for nursing mother and child? Does HSDB 3311 extracts into breast milk? Does HSDB 3311 has any long term or short term side effects on infants? Can HSDB 3311 influence milk supply or can HSDB 3311 decrease milk supply in lactating mothers?

An iron and aluminum chelator that increases the elimination of both metals from the body.Used over short periods to treat acute poisoning from these metals and, over longer periods, to treat chronic iron overload, hemochromatosis, hemosiderosis from repeated transfusions due to thalassemia major or other chronic anemias.Administered subcutaneously, intramuscularly and intravenously. At least three cases have been reported of mothers suffering from thalassemia major who were treated with HSDB 3311 and breast-fed without any problems for the infant or in the iron metabolism of the milk (Pafumi 2000, Surbek 1998). Its low percentage of protein binding makes its excretion in milk possible, but its practically zero oral bioavailability prevents its transfer to the infant’s plasma via ingested breast milk, except in premature babies and the immediate neonatal period in which there may be increased intestinal permeability. According to expert authors, the possible presence of HSDB 3311 in breast milk is unlikely to have harmful effects in the infant (Pafumi 2000, Jensen 1995) so there is no reason to stop breastfeeding during treatment. It may be advisable to control the infant’s serum iron levels.

HSDB 3311 is poorly absorbed orally, so it is not likely to reach the bloodstream of the infant or cause any adverse effects in breastfed infants.[1] Limited information indicates that maternal doses of HSDB 3311 up to 2 grams daily do not affect iron levels in breastmilk and did not cause any adverse effects in two breastfed infants.[2] Some experts advocate breastfeeding in women receiving HSDB 3311 for iron overload caused by beta-thalassemia.[3] If HSDB 3311 is required by the mother, it is not a reason to discontinue breastfeeding. However, since little published information is available on the use of HSDB 3311 during breastfeeding, monitoring of the infant's serum iron is recommended.

A woman with beta-thalassemia restarted HSDB 3311 2 grams subcutaneously 5 days per week 3 days after delivery. She breastfed (extent not stated) one of her twins from birth. After 17 days of breastfeeding, the infant's serum levels were as follows: iron 17.4 micromoles/L, ferritin 200 mcg/L, and transferrin16.8 micromoles/L, all in the normal range. Serum urea, calcium and magnesium were also normal. The second twin was hospitalized for longer and breastfeeding status in the hospital was not reported. Both infants were breastfed (extent not stated) for 4 months postpartum. Both had normal neurologic and motor development at 4 months and laboratory values consistent with their heterozygous beta-thalassemia: hemoglobin F 11.1% and 8.4%, hemoglobin 10.5 g/L and 10.5 g/L, reticulocytes 3.3% and 2.6%, and median erythrocyte volume 60 fL and 58 fL. Their serum levels of iron, ferritin, transferrin, liver enzymes, plasma urea and bilirubin were all normal.[2] A woman with beta-thalassemia gave birth to an infant by cesarean section and breastfed her infant (extent not stated) from birth while receiving HSDB 3311 (dosage not stated). No adverse effects were reported in her infant.[3]