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

Olsalazine lactation summary

Olsalazine is safe in breastfeeding
  • DrLact safety Score for Olsalazine is 1 out of 8 which is considered Safe as per our analyses.
  • A safety Score of 1 indicates that usage of Olsalazine is mostly safe during lactation for breastfed baby.
  • Our study of different scientific research also indicates that Olsalazine does not cause any serious side effects in breastfeeding mothers.
  • Most of scientific studies and research papers declaring usage of Olsalazine safe in breastfeeding are based on normal dosage and may not hold true for higher dosage.
  • Score calculated using the DrLact safety Version 1.2 model, this score ranges from 0 to 8 and measures overall safety of drug in lactation. Scores are primarily calculated using publicly available case studies, research papers, other scientific journals and publically available data.

Answer by Dr. Ru: About Olsalazine usage in lactation

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.

Answer by DrLact: About Olsalazine usage in lactation

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.

Olsalazine Side Effects in Breastfeeding

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]
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