Last update: Aug. 17, 2019

Mesalamine

Very Low Risk for breastfeeding


Safe. Compatible.
Not risky for breastfeeding or infant.

A salicylic derivative with anti-inflammatory, immunosuppressive and bacteriostatic properties, used to treat ulcerative colitis.
Oral or rectal administration 1 to 3 times a day.

Mesalazine is poorly absorbed in the intestine, especially if administered rectally.
Plasma levels are very low and it transfers in very small amounts to breastmilk (Datta 2019), although a metabolite (inactive in order to treat the disease), N-acetyl-5-ASA (Na5ASA), transfers in higher concentrations to breastmilk but without exceeding 10% of the relative dose (Silverman 2005, Christensen 1994, Klotz 1993, Miller 1993, Jenss 1990).

No problems have been observed in more than 130 infants whose mothers were taking it (Datta 2019, Xu 2017, Moretti, 1989), except for some isolated cases of diarrhea (Ito 1993, Nelis 1989, Branski 1986).

Various medical associations, experts and expert consensus consider its use to be safe during breastfeeding (Huang 2016, Nguyen 2016, Damas 2015, Van der Woude 2015, Mahadevan 2015, Schulz 2014, Nielsen 2014, Yarur 2013, Salinger 2012, Habal 2012, Van Assche 2010, van der Woude 2010, Mottet 2009, Heetun 2007, Mahadevan 2006, Connell 1996).

It is very debatable (Sánchez 204) whether the thrombocytosis of a 4-month-old infant whose mother was in chronic treatment with mesalazine was due to mesalazine or to the sudden stopping of breastfeeding (Barriuso 2003).

Alternatives

We do not have alternatives for Mesalamine since it is relatively safe.

Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, and are based on updated scientific publications.
It is not intended to replace the relationship you have with your doctor but to compound it.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Mesalamine is also known as Mesalazine (5-ASA). Here it is a list of alternative known names::


Mesalamine in other languages or writings:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. Rec. 10 - 30. Oral 30 - 50 %
Molecular weight 153 daltons
Protein Binding 40 - 55 %
VD 0,26 l/Kg
pKa 2,02 -
Tmax 4 - 12 hours
T1/2 5ASA 0,6. Na5ASA: 10 hours
M/P ratio 0,3 - 5 -
Theoretical Dose 0,02. Na5ASA: 2,7 mg/Kg/d
Relative Dose 0,03 - 0,06. Na5ASA: 5,4 - 7,4 %

References

  1. Datta P, Rewers-Felkins K, Kallem RR, Baker T, Hale TW. Determination of Mesalamine levels in Human Milk as a Function of Dose. Breastfeed Med. 2019 Mar;14(2):98-101. Abstract
  2. Xu Y, Tan B, Ma L, Song Y, Zhou X, Qi Q, Liu J Inflammatory bowel disease in pregnancy: a report of 7 cases and review of the literature. Int J Clin Exp Med 2017;10(3):5525-5532 2017 Full text (link to original source) Full text (in our servers)
  3. AEMPS-FalkPharma. Mesalazina (Salofalk). Ficha técnica. 2017 Full text (in our servers)
  4. Huang VW, Chang HJ, Kroeker KI, Goodman KJ, Hegadoren KM, Dieleman LA, Fedorak RN. Management of Inflammatory Bowel Disease during Pregnancy and Breastfeeding Varies Widely: A Need for Further Education. Can J Gastroenterol Hepatol. 2016;2016:6193275. Epub 2016 Sep 20. Abstract Full text (link to original source) Full text (in our servers)
  5. Nguyen GC, Seow CH, Maxwell C, Huang V, Leung Y, Jones J, Leontiadis GI, Tse F, Mahadevan U, van der Woude CJ; IBD in Pregnancy Consensus Group.; Canadian Association of Gastroenterology.. The Toronto Consensus Statements for the Management of Inflammatory Bowel Disease in Pregnancy. Gastroenterology. 2016 Mar;150(3):734-757.e1. Abstract
  6. McConnell RA, Mahadevan U. Pregnancy and the Patient with Inflammatory Bowel Disease: Fertility, Treatment, Delivery, and Complications. Gastroenterol Clin North Am. 2016 Abstract
  7. van der Woude CJ, Ardizzone S, Bengtson MB, Fiorino G, Fraser G, Katsanos K, Kolacek S, Juillerat P, Mulders AG, Pedersen N, Selinger C, Sebastian S, Sturm A, Zelinkova Z, Magro F; European Crohn’s and Colitis Organization. The second European evidenced-based consensus on reproduction and pregnancy in inflammatory bowel disease. J Crohns Colitis. 2015 Abstract Full text (link to original source) Full text (in our servers)
  8. Mahadevan U, Matro R. Care of the Pregnant Patient With Inflammatory Bowel Disease. Obstet Gynecol. 2015 Aug;126(2):401-12. Abstract
  9. Damas OM, Deshpande AR, Avalos DJ, Abreu MT. Treating Inflammatory Bowel Disease in Pregnancy: The Issues We Face Today. J Crohns Colitis. 2015 Oct;9(10):928-36. Abstract Full text (in our servers)
  10. Nielsen OH, Maxwell C, Hendel J. IBD medications during pregnancy and lactation. Nat Rev Gastroenterol Hepatol. 2014 Feb;11(2):116-27. Abstract
  11. Schulze H, Esters P, Dignass A. Review article: the management of Crohn's disease and ulcerative colitis during pregnancy and lactation. Aliment Pharmacol Ther. 2014 Nov;40(9):991-1008. Abstract Full text (link to original source) Full text (in our servers)
  12. Yarur A, Kane SV. Update on pregnancy and breastfeeding in the era of biologics. Dig Liver Dis. 2013 Oct;45(10):787-94. Abstract Full text (link to original source) Full text (in our servers)
  13. FDA-Shire. Mesalamine(Pentasa). Drug Summary. 2013 Full text (in our servers)
  14. Selinger CP, Leong RW, Lal S. Pregnancy related issues in inflammatory bowel disease: evidence base and patients' perspective. World J Gastroenterol. 2012 Abstract Full text (link to original source) Full text (in our servers)
  15. Habal FM, Huang VW. Review article: a decision-making algorithm for the management of pregnancy in the inflammatory bowel disease patient. Aliment Pharmacol Ther. 2012 Abstract Full text (link to original source) Full text (in our servers)
  16. van der Woude CJ, Kolacek S, Dotan I, Oresland T, Vermeire S, Munkholm P, Mahadevan U, Mackillop L, Dignass A; European Crohn's Colitis Organisation (ECCO). European evidenced-based consensus on reproduction in inflammatory bowel disease. J Crohns Colitis. 2010 Abstract Full text (link to original source) Full text (in our servers)
  17. Van Assche G, Dignass A, Reinisch W, van der Woude CJ, Sturm A, De Vos M, Guslandi M, Oldenburg B, Dotan I, Marteau P, Ardizzone A, Baumgart DC, D'Haens G, Gionchetti P, Portela F, Vucelic B, Söderholm J, Escher J, Koletzko S, Kolho KL, Lukas M, Mottet C, et al. The second European evidence-based Consensus on the diagnosis and management of Crohn's disease: Special situations. J Crohns Colitis. 2010 Abstract Full text (in our servers)
  18. Mottet C, Vader JP, Felley C, Froehlich F, Gonvers JJ, Juillerat P, Stockbrügger R, Angelucci E, Seibold F, Michetti P, Pittet V; EPACT II Study Group. Appropriate management of special situations in Crohn's disease (upper gastro-intestinal; extra-intestinal manifestations; drug safety during pregnancy and breastfeeding): Results of a multidisciplinary international expert panel-EPACT II. J Crohns Colitis. 2009 Abstract Full text (in our servers)
  19. Heetun ZS, Byrnes C, Neary P, O'Morain C. Review article: Reproduction in the patient with inflammatory bowel disease. Aliment Pharmacol Ther. 2007 Abstract Full text (link to original source) Full text (in our servers)
  20. Mahadevan U, Kane S. American gastroenterological association institute technical review on the use of gastrointestinal medications in pregnancy. Gastroenterology. 2006 Jul;131(1):283-311. Review. Abstract Full text (link to original source) Full text (in our servers)
  21. Silverman DA, Ford J, Shaw I, Probert CS. Is mesalazine really safe for use in breastfeeding mothers? Gut. 2005 Abstract Full text (link to original source) Full text (in our servers)
  22. Sánchez-Marín B, Grasa JM. Trombosis del seno longitudinal superior en un lactante: ¿secundaria a una exposición prolongada a mesalazina? [Thrombosis of the superior sagittal sinus in an infant: secondary to prolonged exposure to mesalazine?]. Rev Neurol. 2004 Jan 16-31;38(2):200. Spanish. (No abstract) Abstract
  23. Barriuso LM, Yoldi-Petri ME, Olaciregui O, Iceta-Lizarraga A, Goñi-Orayen C. Trombosis del seno longitudinal superior en un lactante: ¿secundaria a una exposición prolongada a mesalazina? [Thrombosis of the superior sagittal sinus in a breast fed infant: secondary to prolonged exposure to mesalazine?]. Rev Neurol. 2003 Jun 16-30;36(12):1142-4. Spanish. Abstract
  24. Kanenguiser P, Goyheneche B, Filinger E. Aminosalicilatos: Características de las Formulaciones Orales Utilizadas en el Tratamiento de la Enfermedad Inflamatoria Intestinal. Lat. Am. J. Pharm. 22 (3): 255-60 2003 Full text (link to original source) Full text (in our servers)
  25. Moretti Myla Emily. Prospective follow-up of infants exposed to 5-aminosalicylic acid containing drugs through maternal milk. Thesis. Department of Pharmacology \ University of Toronto 1998 Full text (link to original source) Full text (in our servers)
  26. Connell WR. Safety of drug therapy for inflammatory bowel disease in pregnant and nursing women. Inflamm Bowel Dis. 1996 Abstract
  27. 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 May;73(5):399-402. Abstract
  28. Miller LG, Hopkinson JM, Motil KJ, Corboy JE, Andersson S. Disposition of olsalazine and metabolites in breast milk. J Clin Pharmacol. 1993 Abstract
  29. Klotz U, Harings-Kaim A. Negligible excretion of 5-aminosalicylic acid in breast milk. Lancet. 1993 Abstract
  30. 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 May;168(5):1393-9. Abstract
  31. Jenss H, Weber P, Hartmann F. 5-Aminosalicylic acid and its metabolite in breast milk during lactation. Am J Gastroenterol. 1990 Abstract
  32. Nelis GF. Diarrhoea due to 5-aminosalicylic acid in breast milk. Lancet. 1989 Abstract
  33. Branski D, Kerem E, Gross-Kieselstein E, Hurvitz H, Litt R, Abrahamov A. Bloody diarrhea--a possible complication of sulfasalazine transferred through human breast milk. J Pediatr Gastroenterol Nutr. 1986 Mar-Apr;5(2):316-7. Abstract

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