Balsalazide

Drug Levels and Effects:




Summary of Use during Lactation:


Although no information exists on the excretion of balsalazide 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. European experts consider mesalamine derivatives to be safe during breastfeeding.[1] If balsalazide is required by the mother, it is not a reason to discontinue breastfeeding, but observe breastfed infants for diarrhea.


Drug Levels:


Balsalazideis a prodrug that liberates the active drug, mesalamine (5-aminosalicylic acid; 5-ASA), in the gastrointestinal tract. Mesalamine is metabolized to N-acetyl-5-ASA which is inactive in treating inflammatory bowel disease, but its possible effects on the breastfed infant are unknown.

Maternal Levels.

Relevant published information was not found as of the revision date.

Infant Levels.

Relevant published information was not found as of the revision date.


Effects in Breastfed Infants:


The active metabolite of balsalazide , 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.[2]

Diarrhea has also been reported anecdotally by some nursing mothers taking mesalamine,[3] 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.[4]


Possible Effects on Lactation:


Relevant published information was not found as of the revision date.


Alternate Drugs to Consider:


Mesalamine,Sulfasalazine


References:


1. van der Woude CJ, Kolacek S, Dotan I et al. European evidenced-based consensus on reproduction in inflammatory bowel disease. J Crohn's Colitis. 2010;4:493-510. PMID:21122553
2. Nelis GF. Diarrhoea due to 5-aminosalicylic acid in breast milk. Lancet. 1989;333:383. Letter. PMID:2563532
3. Ito S, Blajchman A, Stephenson M, Eliopoulos C, Koren G. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993;168:1393-9. PMID:8498418
4. Moretti ME, Spiczynski Y, Hashemi G et al. Prospective follow-up of infants exposed to 5-aminosalicylic acid containing drugs through maternal milk. J Clin Pharmacol. 1998;38:867. Abstract.



Substance Identification:




Substance Name:

Balsalazide

CAS Registry Number:

82101-18-6

Drug Class:


  • Anti-Inflammatory Agents, Non-Steroidal

  • Gastrointestinal Agents


  • Administrative Information:




    LactMed Record Number:


    589


    Last Revision Date:


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