The Basics
What is Mesalamine?
Used to treat ulcerative colitis by reducing symptoms such as diarrhea, rectal bleeding, and stomach pain.
Brand names for Mesalamine
Asacol
How Mesalamine is classified
Gastrointestinal Agents, Anti-Inflammatory Agents – Non-Steroidal
Mesalamine During Pregnancy
Mesalamine pregnancy category
Category CNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.
What we know about taking Mesalamine while pregnant
N/A
Taking Mesalamine While Breastfeeding
What are recommendations for lactation if you're taking Mesalamine?
Mesalamine is poorly excreted into breastmilk. However, 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 mesalamine is required by the mother, it is not a reason to discontinue breastfeeding, but carefully observe breastfed infants for diarrhea during maternal use of mesalamine.
Maternal / infant drug levels
Mesalamine is poorly excreted into breastmilk. However, 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 mesalamine is required by the mother, it is not a reason to discontinue breastfeeding, but carefully observe breastfed infants for diarrhea during maternal use of mesalamine.
Possible effects of Mesalamine on milk supply
Relevant published information was not found as of the revision date.
Possible alternatives to Mesalamine
Olsalazine, Sulfasalazine.
List of References
Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Nielsen OH, Maxwell C, Hendel J. IBD medications during pregnancy and lactation. Nat Rev Gastroenterol Hepatol. 2014;11:116-27. PMID: 23897285
2. Mahadevan U, Matro R. Care of the pregnant patient with inflammatory bowel disease. Obstet Gynecol. 2015;126:401-12. PMID: 26241432
3. Nguyen GC, Seow CH, Maxwell C et al. The Toronto Consensus Statements for the Management of IBD in Pregnancy. Gastroenterology. 2016;150:734-57. PMID: 26688268
4. van der Woude CJ, Ardizzone S, Bengtson MB et al. The second European evidenced-based consensus on reproduction and pregnancy in inflammatory bowel disease. J Crohns Colitis. 2015;9:107-24. PMID: 25602023
5. Jenss H, Weber P, Hartmann F. 5-Aminosalicylic acid and its metabolites in breast milk during lactation. Am J Gastroenterol. 1990;85:331. Letter. PMID: 2309691
6. Klotz U, Harings-Kaim A. Negligible excretion of 5-aminosalicylic acid in breast milk. Lancet. 1993;342:618-9. Letter. PMID: 8102746
7. Christensen LA, Rasmussen SN, Hansen SH. Disposition of 5-aminosalicylic acid and N-acetyl-5-aminosalicylic acid in fetal and maternal body fluids during treatment with different 5-aminosalicylic acid preparations. Acta Obstet Gynecol Scand. 1994;73:399-402. PMID: 8009971
8. Silverman DA, Ford J, Shaw I et al. Is mesalazine really safe for use in breastfeeding mothers? Gut. 2005;54:170-1. PMID: 15591526
9. Datta P, Rewers-Felkins K, Kallem RR et al. Determination of mesalamine levels in human milk as a function of dose. Breastfeed Med. 2019;14:98-101. PMID: 30431332
10. Nelis GF. Diarrhoea due to 5-aminosalicylic acid in breast milk. Lancet. 1989;333:383. Letter. PMID: 2563532
11. Barriuso LM, Yoldi-Petri ME, Olaciregui O et al. [Thrombosis of the superior sagittal sinus in a breast fed infant: secondary to prolonged exposure to mesalazine?]. Rev Neurol. 2003;36:1142-4. PMID: 12833232
12. Ito S, Blajchman A, Stephenson M et al. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993;168:1393-9. PMID: 8498418
13. 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 (Suppl):867. Abstract.
14. Xu YL, Tan B, Ma LK et al. Inflammatory bowel disease in pregnancy: A report of 7 cases and review of the literature. Int J Clin Exp Med. 2017;10:5525-32. http://www.ijcem.com/V10_No3.html
Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.
