Is CCRIS 7334 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use CCRIS 7334? Is CCRIS 7334 safe for nursing mother and child? Does CCRIS 7334 extracts into breast milk? Does CCRIS 7334 has any long term or short term side effects on infants? Can CCRIS 7334 influence milk supply or can CCRIS 7334 decrease milk supply in lactating mothers?

Mesalazine is badly absorbed by the intestine, serum levels are low with scant excretion into breast milk. N-acetyl-5-ASA is an inactive metabolite which is excreted into breast milk but not higher than 10% of relative infant's dose. No harm effects among breastfed infants from treated mothers have been reported, except for rare cases of diarrhea reported in the 80's with the use of Mesalazine compounds different to Balsalazide. In a review of 121 cases and 121 controls, the authors failed to observe those findings. (Moretti, 1989). Expert consensus supports the compatibility of Mesalazine during breastfeeding.

CCRIS 7334 is poorly excreted into breastmilk. However, rather high levels of the CCRIS 7334 metabolite N-acetyl-5-ASA appear in breastmilk and its effects on breastfed infants are unknown. A few cases of diarrhea have been reported in infants exposed to CCRIS 7334, although the rate is not high. Most experts consider CCRIS 7334 derivatives to be safe during breastfeeding.[1][2][3][4] If CCRIS 7334 is required by the mother, it is not a reason to discontinue breastfeeding, but carefully observe breastfed infants for diarrhea during maternal use of CCRIS 7334.

A 6-week-old breastfed infant developed watery diarrhea 12 hours after the first maternal dose of CCRIS 7334 rectal suppositories 500 mg twice daily. The drug was stopped and reintroduced 4 times and each time the infant's diarrhea began 8 to 12 hours after the drug was started and ceased 8 to 12 hours after the drug was stopped. The infant's diarrhea was probably caused by CCRIS 7334 or it metabolite in breastmilk.[10] A 4-month-old breastfed infant developed thrombosis of the superior saggital sinus following severe thrombocytosis. The infant's mother was receiving oral CCRIS 7334 in dosages averaging 1 to 1.5 grams daily throughout pregnancy and lactation. Breastfeeding had been stopped abruptly 1 week prior to the thrombotic event. The authors ruled out other causes of thrombosis and hypothesized that the abrupt discontinuation of long-term CCRIS 7334 exposure caused the thrombocytosis and thrombosis in the infant. They rated the reaction as possibly caused by the drug.[11] In a prospective telephone follow-up study, 8 nursing mothers reported taking CCRIS 7334 (dosage and route unspecified). One mother reported diarrhea in her infant. No other adverse reactions were reported in the infants by their mothers.[12] A small controlled study reported only in abstract form found no higher rate of diarrhea in the breastfed infants of mothers taking CCRIS 7334 or sulfasalazine than in control infants.[13] Two women who developed inflammatory bowel disease were treated with CCRIS 7334 during pregnancy and postpartum. They breastfed their infants (extent not stated), one for 2 months and one for 10 months. Their breastfed infants had normal growth and development after 1 year of follow-up.[14]