Is HSDB 3201 Safe in Breastfeeding

Question

I am a breastfeeding mother and i want to know if it is safe to use HSDB 3201? Is HSDB 3201 safe for nursing mother and child? Does HSDB 3201 extracts into breast milk? Does HSDB 3201 has any long term or short term side effects on infants? Can HSDB 3201 influence milk supply or can HSDB 3201 decrease milk supply in lactating mothers?

HSDB 3201 lactation summary

DrLact safety Score for HSDB 3201 is 1 out of 8 which is considered Safe as per our analyses.
A safety Score of 1 indicates that usage of HSDB 3201 is mostly safe during lactation for breastfed baby.
Our study of different scientific research also indicates that HSDB 3201 does not cause any serious side effects in breastfeeding mothers.
Most of scientific studies and research papers declaring usage of HSDB 3201 safe in breastfeeding are based on normal dosage and may not hold true for higher 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 3201 usage in lactation

Its high plasma protein-binding capacity would explain the very low excretion observed into breast milk (Houwert-de Jong 1981, Nava 2004). No clinical side-effects and/or blood test disarrangements were observed in infants whose mothers were treated with HSDB 3201 (Houwert-de Jong 1981, Fondevila 1989).

Answer by DrLact: About HSDB 3201 usage in lactation

HSDB 3201 is not approved for marketing in the United States by the U.S. Food and Drug Administration, but is available in Canada and other countries. Because of the low levels of HSDB 3201 in breastmilk, amounts ingested by the infant are small. No changes in coagulation measurements or adverse reactions in breastfed infants have been reported from maternal HSDB 3201 use during lactation. There is a consensus that maternal HSDB 3201 therapy during breastfeeding poses little risk to the breastfed infant.[1][2][3][4][5][6] No special precautions are necessary.

HSDB 3201 Side Effects in Breastfeeding

Nineteen infants were breastfed (extent not stated) while their mothers were anticoagulated with HSDB 3201 immediately postpartum. Despite not receiving prophylactic vitamin K at birth, none of the infants had abnormal blood clotting as measured by the Thrombotest after at least 5 days of maternal therapy.[1] Seven infants were exclusively breastfed by mothers who were receiving long-term anticoagulation with HSDB 3201 for thromboprophylaxis following heart valve replacement. All women were therapeutically anticoagulated and receiving an average of 21 mg of HSDB 3201 per week (range 12 to 45 mg per week). Each infant received 1 mg of vitamin K prophylactically at birth and had their prothrombin time measured after at least 7 days of breastfeeding. The prothrombin times of the infants was not different from those of a control group of 42 breastfed infants whose mothers were not anticoagulated. No instances of bleeding were reported.[2]