Is Olsalazine Sodium Safe in Breastfeeding

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

Prodrug of Mesalazine: Medication compounded by union of two molecules of 5-ASA resulting in a dimer which is degraded into monomeric Mesalazine (5-ASA) in the large intestine. Mesalazine is badly absorbed by the intestine, serum levels are low with scant excretion into breast milk. Traces of Olsalazine and/or Mesalazine have not been found in breast milk of treated mothers with Olsalazine. N-acetyl-5-ASA is an inactive metabolite which is excreted into breast milk but not higher than 1% 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 Olsalazine. 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.

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

One infant was breastfed during maternal therapy with olsalazine for Crohn's disease. After 2 and 3 weeks of therapy, no rash, wheezing, vomiting or diarrhea were noted in the infant.[5] The active metabolite of olsalazine, mesalamine, was probably responsible for diarrhea in a 6-week-old whose diarrhea recurred 4 times after rechallenge of the mother 4 times during breastfeeding.[7] Diarrhea has also been reported anecdotally by some nursing mothers,[8] but a small controlled study reported only in abstract form found no higher rate of diarrhea in the breastfed infants of mothers taking mesalamine than in control infants.[9]