Is HSDB 3395 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use HSDB 3395? Is HSDB 3395 safe for nursing mother and child? Does HSDB 3395 extracts into breast milk? Does HSDB 3395 has any long term or short term side effects on infants? Can HSDB 3395 influence milk supply or can HSDB 3395 decrease milk supply in lactating mothers?

Prodrug of Mesalazine: medication compounded by union of Sulfapyridine and 5-ASA which is degraded into Mesalazine by bacteria in the large intestine. Mesalazine is badly absorbed by the intestine, serum levels are low with scant excretion into breast milk. Inactive metabolite N-acetyl-5-ASA was found in small amount in the milk with a relative infant dose not higher than 10%. 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 HSDB 3395. 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 and/or its prodrugs during breastfeeding. Sulfapyridine released in the large intestine is 60% absorbed with a protein-binding capacity of 90%, both being a reason for low excretion into breast milk. Mesalazine derivatives that not contain Sulfapyridine are recommended by some authors for use while breastfeeding (see alternative drugs).

HSDB 3395 and its active metabolite mesalamine are poorly excreted into breastmilk. However, rather high levels of the mesalamine metabolite N-acetyl-5-ASA appear in breastmilk and its effects on breastfed infants are unknown. Another HSDB 3395 metabolite, sulfapyridine, also appears in milk and infant serum and might cause hemolysis, especially in newborn infants and in those with glucose-6-phosphate dehydrogenase (G6PD) deficiency. The time of greatest risk for hemolysis in fullterm newborns without G6PD deficiency might be as short as 8 days after birth.[1] Bloody diarrhea has occurred in an infant whose mother was taking HSDB 3395 and a few cases of diarrhea have been reported in infants exposed to mesalamine in breastmilk, although the rate is not high. Most experts consider mesalamine derivatives to be safe during breastfeeding.[2][3][4][5][6][7] If HSDB 3395 is required by the mother, it is not a reason to discontinue breastfeeding, but carefully observe breastfed infants for diarrhea. Other mesalamine derivatives that do not contain a sulfonamide are preferred.

One group of investigators stated that they had 10 years of experience using HSDB 3395 during the puerperium with no obvious adverse effects in breastfed infants.[8] The breastfed infant of a mother taking HSDB 3395 500 mg 4 times daily beginning at 4.5 months postpartum experienced no adverse effects during 2.5 months of nursing.[10] A 2-month-old breastfed infant whose mother was taking HSDB 3395 3 grams daily had an episode of bloody diarrhea. The bloody diarrhea recurred 2 weeks later and persisted until 3 months of age. The infant had up to 6 bowel movements daily and the stools had a loose consistency and were mixed with fresh blood. A colonoscopy revealed a mild inflammatory process and numerous punctate erosions in the mucosa. The infant had a sulfapyridine blood level of 5.3 mg/L, which may have been enhanced because the infant's mother was a slow acetylator. The bloody diarrhea stopped 48 to 72 hours after the mother stopped taking HSDB 3395. A repeat colonoscopy at 4.5 months of age was normal and no further bloody diarrhea occurred up to 14 months of follow-up. The authors felt that the reaction was likely caused by an allergic reaction to sulfapyridine.[13] The reaction was probably caused by HSDB 3395 or one of its metabolites in breastmilk. Both sulfapyridine and mesalamine have been reported to cause diarrhea in breastfed infants.[14][15] Eight infants whose mothers were taking HSDB 3395 in average dosage of 2.6 grams daily were breastfed. Sulfapyridine was detectable in 5 infant's serum in levels ranging from 1 to 4.8 mg/L. The authors pointed out that these levels were far below those required to displace bilirubin from serum albumin binding sites.[12] A small controlled study reported only in abstract form found no higher rate of diarrhea in the breastfed infants of mothers taking mesalamine or HSDB 3395 than in control infants.[16] A woman with Crohn's disease used HSDB 3395 4 g/day during pregnancy and postpartum. During breastfeeding (extent not stated) she also received infliximab 5 mg/kg every 8 weeks and prednisone 60 mg/day in a tapering schedule. At 6 months of age, the infant was asymptomatic with regular weight gain.[17]