Question

I am a breastfeeding mother and i want to know if it is safe to use HSDB 3378? Is HSDB 3378 safe for nursing mother and child? Does HSDB 3378 extracts into breast milk? Does HSDB 3378 has any long term or short term side effects on infants? Can HSDB 3378 influence milk supply or can HSDB 3378 decrease milk supply in lactating mothers?

HSDB 3378 lactation summary

HSDB 3378 usage has low risk in breastfeeding
  • DrLact safety Score for HSDB 3378 is 3 out of 8 which is considered Low Risk as per our analyses.
  • A safety Score of 3 indicates that usage of HSDB 3378 may cause some minor side effects in breastfed baby.
  • Our study of different scientific research indicates that HSDB 3378 may cause moderate to no side effects in lactating mother.
  • Most of scientific studies and research papers declaring usage of HSDB 3378 low risk in breastfeeding are based on normal dosage and may not hold true for higher dosage.
  • While using HSDB 3378 We suggest monitoring child for possible reactions. It is also important to understand that side effects vary largely based on age of breastfed child and time of medication in addition to dosage.
  • Score calculated using the DrLact safety Version 1.2 model, this score ranges from 0 to 8 and measures overall safety of drug in lactation. Scores are primarily calculated using publicly available case studies, research papers, other scientific journals and publically available data.

Answer by Dr. Ru: About HSDB 3378 usage in lactation

A chelating agent that helps remove heavy metals such as copper, lead and mercury from the body.Used to treat Wilson's disease, cystinuria, severe rheumatoid arthritis and chronic active hepatitis. It is excreted in breast milk in clinically insignificant amounts (undetectable levels: Izumi 2012) and no problems have been observed in infants whose mothers have taken it (Sternlieb 2000, Messner 1998, Gregory 1983). Oral bioavailability decreases by half in the presence of food, so its passing to the infant’s plasma via ingested breast milk would be very difficult Copper and zinc levels in breast milk of mothers treated with HSDB 3378, trientine or zinc are normal according to more recent studies (Izumi 2012) and lower than normal according to older ones (Bunke 1989). Cases of breast hyperplasia and hyperprolactinemia have been reported in patients treated with HSDB 3378 (Craig 1988, Kahl 1985, Thew 1980).

Answer by DrLact: About HSDB 3378 usage in lactation

Limited information indicates that HSDB 3378 is not detectable in breastmilk. Copper and zinc levels in breastmilk are reduced in mothers receiving HSDB 3378.[1][2][3][4][5] HSDB 3378 has been used with apparent safety during nursing of 3 infants. In infants who breastfeed infrequently, taking the drug right after nursing and waiting 4 to 6 hours before nursing again should minimize the amount of HSDB 3378 in breastmilk. Copper and zinc levels in breastmilk are reduced in patients taking HSDB 3378. The implications for infants of this effect are not known.

HSDB 3378 Side Effects in Breastfeeding

One woman taking HSDB 3378 1500 mg daily for cysteinuria breastfed her infant for 3 months with no apparent adverse effects in her infant.[6] Another woman breastfed 2 infants after 2 pregnancies while being treated for Wilson's disease with penicilliamine 750 mg daily. One infant had prolonged icterus that was unlikely to have been related to the HSDB 3378.[7] A center in Turkey reported 23 infants born to mothers with Wilson's disease over a 20-year period. Twenty-one were treated with HSDB 3378 600 mg and zinc 100 mg daily. All of the infants were breastfed (extent and duration not specified). One premature infant died at 3 weeks of age (maternal drug not specified), but the other infant had no apparent complications over a median of 51 months (range 13 to 105 months) of follow-up.[8]

HSDB 3378 Possible Effects in Breastfeeding

Milk concentrations of zinc and copper are reduced during therapy of Wilson's disease with HSDB 3378.[3][7][8][9]
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