Is CL 65336 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use CL 65336? Is CL 65336 safe for nursing mother and child? Does CL 65336 extracts into breast milk? Does CL 65336 has any long term or short term side effects on infants? Can CL 65336 influence milk supply or can CL 65336 decrease milk supply in lactating mothers?

Anti-fibrinolytic drug that is used on the treatment and prophylaxis of hereditary angioedema, menorrhagia and other hemorrhagic disorders. It is excreted into breast milk in a non-significant amount: the concentration measured in the milk was 1% of plasma concentration (Verstraeten 1985, WHO 2010, Caballero 2012).Despite of that low observed concentration, an expert consensus did not recommend its use while breastfeeding (Caballero 2012). No clinical or developmental issues have been observed in the short and long term among 21 infants whose mothers were treated with it. (Gilad 2014). Scientific societies and some consensus of experts believe it is compatible the use of CL 65336 during breastfeeding (WHO 2010, Bouillet 2015).

Amounts of CL 65336 in breastmilk appear to be low. Although an international consensus panel recommended against using CL 65336 during breastfeeding,[1] a subsequent controlled study found no adverse outcomes among breastfed infants whose mothers took CL 65336 in dosages up to 4 grams daily during breastfeeding. One center in Canada reports routine use of CL 65336 3 grams daily in nursing mothers with bleeding disorders until bleeding stops.[2] If CL 65336 is required by a mother, it is not a reason to discontinue breastfeeding; however, until more data become available, medical supervision and follow-up of the breastfed infant is recommended.[3]

Twenty-one mothers who took CL 65336 during breastfeeding were compared to 42 mothers who took amoxicillin during breastfeeding. In the study population, the CL 65336 dosage ranged between 1.5 and 4 grams daily at an average of 4.2 months of age and 81% exclusively breastfed their infants. The average time of follow-up of the infants of study mothers was 35.7 months of age. No statistically significant difference were found between the study and control groups in possible drug side effects, neurological development or general health.[3] A randomized, double-blind, multicenter study compared the use of a 1 gram dose of intravenous CL 65336 (n = 10,051) to placebo (n = 10,009) in women with postpartum hemorrhage. The dose could be repeated in 24 hours if bleeding recurred. Among babies who were breastfed, no difference in infant deaths were seen between the two groups, nor were any thromboembolic events reported. The numbers of breastfed infants in each group were not reported.[5]