Is G23350 Safe in Breastfeeding

Question

I am a breastfeeding mother and i want to know if it is safe to use G23350? Is G23350 safe for nursing mother and child? Does G23350 extracts into breast milk? Does G23350 has any long term or short term side effects on infants? Can G23350 influence milk supply or can G23350 decrease milk supply in lactating mothers?

G23350 lactation summary

DrLact safety Score for G23350 is 1 out of 8 which is considered Safe as per our analyses.
A safety Score of 1 indicates that usage of G23350 is mostly safe during lactation for breastfed baby.
Our study of different scientific research also indicates that G23350 does not cause any serious side effects in breastfeeding mothers.
Most of scientific studies and research papers declaring usage of G23350 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 G23350 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 G23350 (Houwert-de Jong 1981, Fondevila 1989).

Answer by DrLact: About G23350 usage in lactation

G23350 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 G23350 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 G23350 use during lactation. There is a consensus that maternal G23350 therapy during breastfeeding poses little risk to the breastfed infant.[1][2][3][4][5][6] No special precautions are necessary.

G23350 Side Effects in Breastfeeding

Nineteen infants were breastfed (extent not stated) while their mothers were anticoagulated with G23350 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 G23350 for thromboprophylaxis following heart valve replacement. All women were therapeutically anticoagulated and receiving an average of 21 mg of G23350 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]