Is SPD 476 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use SPD 476? Is SPD 476 safe for nursing mother and child? Does SPD 476 extracts into breast milk? Does SPD 476 has any long term or short term side effects on infants? Can SPD 476 influence milk supply or can SPD 476 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.

SPD 476 is poorly excreted into breastmilk. However, rather high levels of the SPD 476 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 SPD 476, although the rate is not high. Most experts consider SPD 476 derivatives to be safe during breastfeeding.[1][2][3][4] If SPD 476 is required by the mother, it is not a reason to discontinue breastfeeding, but carefully observe breastfed infants for diarrhea during maternal use of SPD 476.

A 6-week-old breastfed infant developed watery diarrhea 12 hours after the first maternal dose of SPD 476 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 SPD 476 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 SPD 476 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 SPD 476 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 SPD 476 (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 SPD 476 or sulfasalazine than in control infants.[13] Two women who developed inflammatory bowel disease were treated with SPD 476 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]