Question

I am a breastfeeding mother and i want to know if it is safe to use EINECS 201-919-1? Is EINECS 201-919-1 safe for nursing mother and child? Does EINECS 201-919-1 extracts into breast milk? Does EINECS 201-919-1 has any long term or short term side effects on infants? Can EINECS 201-919-1 influence milk supply or can EINECS 201-919-1 decrease milk supply in lactating mothers?

EINECS 201-919-1 lactation summary

EINECS 201-919-1 is safe in breastfeeding
  • DrLact safety Score for EINECS 201-919-1 is 1 out of 8 which is considered Safe as per our analyses.
  • A safety Score of 1 indicates that usage of EINECS 201-919-1 is mostly safe during lactation for breastfed baby.
  • Our study of different scientific research also indicates that EINECS 201-919-1 does not cause any serious side effects in breastfeeding mothers.
  • Most of scientific studies and research papers declaring usage of EINECS 201-919-1 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 EINECS 201-919-1 usage in lactation

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.

Answer by DrLact: About EINECS 201-919-1 usage in lactation

EINECS 201-919-1 is poorly excreted into breastmilk. However, rather high levels of the EINECS 201-919-1 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 EINECS 201-919-1, although the rate is not high. Most experts consider EINECS 201-919-1 derivatives to be safe during breastfeeding.[1][2][3][4] If EINECS 201-919-1 is required by the mother, it is not a reason to discontinue breastfeeding, but carefully observe breastfed infants for diarrhea during maternal use of EINECS 201-919-1.

EINECS 201-919-1 Side Effects in Breastfeeding

A 6-week-old breastfed infant developed watery diarrhea 12 hours after the first maternal dose of EINECS 201-919-1 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 EINECS 201-919-1 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 EINECS 201-919-1 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 EINECS 201-919-1 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 EINECS 201-919-1 (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 EINECS 201-919-1 or sulfasalazine than in control infants.[13] Two women who developed inflammatory bowel disease were treated with EINECS 201-919-1 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]
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.