Question

I am a breastfeeding mother and i want to know if it is safe to use BX 661A? Is BX 661A safe for nursing mother and child? Does BX 661A extracts into breast milk? Does BX 661A has any long term or short term side effects on infants? Can BX 661A influence milk supply or can BX 661A decrease milk supply in lactating mothers?

BX 661A lactation summary

BX 661A is safe in breastfeeding
  • DrLact safety Score for BX 661A is 1 out of 8 which is considered Safe as per our analyses.
  • A safety Score of 1 indicates that usage of BX 661A is mostly safe during lactation for breastfed baby.
  • Our study of different scientific research also indicates that BX 661A does not cause any serious side effects in breastfeeding mothers.
  • Most of scientific studies and research papers declaring usage of BX 661A 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 BX 661A usage in lactation

Prodrug of Mesalamine: medication compounded by Mesalazine and an inert transporter that is degraded by bacteria into Mesalazine (5-ASA) in the large intestine. It is badly absorbed by the intestine, serum levels are low with scant excretion into breast milk. 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 BX 661A. 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 BX 661A usage in lactation

Although no information exists on the excretion of BX 661A into breastmilk, it is metabolized to the active drug mesalamine. 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 BX 661A is required by the mother, it is not a reason to discontinue breastfeeding, but observe breastfed infants for diarrhea.

BX 661A Side Effects in Breastfeeding

The active metabolite of BX 661A, 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.[5] Diarrhea has also been reported anecdotally by some nursing mothers taking mesalamine,[6] 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.[7]
Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. We do not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.