Is Mesalazine compatible with breastfeeding? Do we have alternatives for Mesalazine?

Mesalazine

August 10, 2018 (Very Low Risk)

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

Mesalazine is poorly absorbed in the intestine, especially if the administration is rectally; the plasma levels are very low and it passes in small amount to milk, although a metabolite (inactive to treat the disease), N-acetyl-5-ASA (Na5ASA), passes in higher concentration to milk but without exceeding 10% of the relative dose (Silverman 2005, Christensen 1994, Klotz 1993, Miller 1993, Jenss 1990).

No problems have been described in more than 120 infants of mothers who took Mesalazine (Xu 2017, Moretti, 1989), except for some isolated case of diarrhea (Ito 1993, Nelis 1989, Branski 1986).

Expert consensus supports the compatibility of Mesalazine 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 ).

Is highly debatable (Sánchez 204) thrombocytosis who had a 4-month infant whose mother was chronically treated with mesalazine, was due to mesalazine or abrupt cessation of breastfeeding (Barriuso 2003).

Alternatives

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

Very Low Risk

Compatible. Not risky for breastfeeding or infant.

Low Risk

Moderately safe. Mild risk possible. Follow up recommended. Read the Comment.

High Risk

Poorly safe. Evaluate carefully. Use a safer alternative. Read the Comment.

Very High Risk

Not recommended. Cessation of breastfeeding or alternative.

Synonyms

  • 5-AminoSalicylic Acid
  • 5-ASA
  • Fisalamine
  • Mesalamine

Writings

  • ميزالازين (Arabic)
  • Месалазин (Cyrillic)
  • 美沙拉秦 (Chinese)
  • メサラジン (Japanese)
  • C7 H7 NO3 (Molecular formula)
  • 5-Amino-2-salicylic acid (Chemical name)
  • A07EC02 (ATC Code/s)

Drug trade names

References

  1. AEMPS-FalkPharma. Mesalazina (Salofalk). Ficha técnica. 2017 Full text (in our servers)
  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. McConnell RA, Mahadevan U. Pregnancy and the Patient with Inflammatory Bowel Disease: Fertility, Treatment, Delivery, and Complications. Gastroenterol Clin North Am. 2016Abstract
  4. 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. 2016Abstract
  5. 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. 2016Abstract Full text (link to original source) Full text (in our servers)
  6. 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. 2015Abstract Full text (link to original source) Full text (in our servers)
  7. Damas OM, Deshpande AR, Avalos DJ, Abreu MT. Treating Inflammatory Bowel Disease in Pregnancy: The Issues We Face Today. J Crohns Colitis. 2015Abstract Full text (in our servers)
  8. Mahadevan U, Matro R. Care of the Pregnant Patient With Inflammatory Bowel Disease. Obstet Gynecol. 2015Abstract
  9. Schulze H, Esters P, Dignass A. Review article: the management of Crohn's disease and ulcerative colitis during pregnancy and lactation. Aliment Pharmacol Ther. 2014Abstract Full text (link to original source) Full text (in our servers)
  10. Nielsen OH, Maxwell C, Hendel J. IBD medications during pregnancy and lactation. Nat Rev Gastroenterol Hepatol. 2014Abstract
  11. FDA-Shire. Mesalamine(Pentasa). Drug Summary. 2013 Full text (in our servers)
  12. Yarur A, Kane SV. Update on pregnancy and breastfeeding in the era of biologics. Dig Liver Dis. 2013Abstract Full text (link to original source) Full text (in our servers)
  13. Selinger CP, Leong RW, Lal S. Pregnancy related issues in inflammatory bowel disease: evidence base and patients' perspective. World J Gastroenterol. 2012Abstract Full text (link to original source) Full text (in our servers)
  14. Habal FM, Huang VW. Review article: a decision-making algorithm for the management of pregnancy in the inflammatory bowel disease patient. Aliment Pharmacol Ther. 2012Abstract Full text (link to original source) Full text (in our servers)
  15. 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. 2010Abstract 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. 2010Abstract Full text (link to original source) Full text (in our servers)
  17. 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. 2009Abstract Full text (in our servers)
  18. Heetun ZS, Byrnes C, Neary P, O'Morain C. Review article: Reproduction in the patient with inflammatory bowel disease. Aliment Pharmacol Ther. 2007Abstract Full text (link to original source) Full text (in our servers)
  19. Mahadevan U, Kane S. American gastroenterological association institute technical review on the use of gastrointestinal medications in pregnancy. Gastroenterology. 2006Abstract Full text (link to original source) Full text (in our servers)
  20. Silverman DA, Ford J, Shaw I, Probert CS. Is mesalazine really safe for use in breastfeeding mothers? Gut. 2005Abstract Full text (link to original source) Full text (in our servers)
  21. 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. 2004Abstract
  22. 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. 2003Abstract
  23. 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)
  24. 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)
  25. Connell WR. Safety of drug therapy for inflammatory bowel disease in pregnant and nursing women. Inflamm Bowel Dis. 1996Abstract
  26. 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. 1994Abstract
  27. 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. 1993Abstract
  28. Miller LG, Hopkinson JM, Motil KJ, Corboy JE, Andersson S. Disposition of olsalazine and metabolites in breast milk. J Clin Pharmacol. 1993Abstract
  29. Klotz U, Harings-Kaim A. Negligible excretion of 5-aminosalicylic acid in breast milk. Lancet. 1993Abstract
  30. Jenss H, Weber P, Hartmann F. 5-Aminosalicylic acid and its metabolite in breast milk during lactation. Am J Gastroenterol. 1990Abstract
  31. Nelis GF. Diarrhoea due to 5-aminosalicylic acid in breast milk. Lancet. 1989Abstract
  32. 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. 1986Abstract