Last update Feb. 1, 2022
Very Low Risk
Prodrug of Mesalazine: Sulfasalazine is a compound of a sulfonamide (sulfapyridine) and an anti-inflammatory (5-aminosalicylic acid, 5-ASA, or mesalazine). In the colon, bacteria break down sulfasalazine into sulfapyridine and mesalazine (Klotz 1985). Used in inflammatory bowel disease and rheumatoid arthritis. Oral and rectal administration in 2 to 4 daily doses.
No problems have been observed in infants of mothers treated with sulfasalzine (Ikram 2021, Correia 2010, Khan 1979), except for rare cases of diarrhea reported in the 80's with the use of Sulfasalazine (Nelis 1989, Branski 1986). In a review of 121 cases and 121 controls, the authors failed to observe those findings. (Moretti, 1998) . (Ikram 2021, Correia 2010, Khan 1979). Plasma levels in these infants were very low. (Esbjörner 1987, Berlin 1980)
Mesalazine is badly absorbed by the intestine, serum levels are low with scant excretion into breast milk (Klotz 1993, Jenss 1990, Christensen 1994 y 1987, Miller 1993, Berlin 1980). Plasma levels in these infants were very low (Silverman 2005, Berlin 1980). Inactive metabolite N-acetyl-5-ASA was found in small amount in the milk with a relative infant dose not higher than 10%.(Silverman 2005, Jenss 1990)
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)
Sulfapyridine released in the large intestine is 60% absorbed with a protein-binding capacity of 90%, both being a reason for low excretion into breast milk. (Ambrosius 1987, Esbjörner 1987, Berlin 1980, Järnerot 1979, Khan 1979)
Expert consensus supports the compatibility of Mesalazine and/or its prodrugs during breastfeeding. (Sammaritano 2020 y 2014, Mahadevan 2019, 2015 y 2006, Nguyen 2016, Flint 2016, Götestam 2016, Huang 2016, McConnell 2016, Damas 2015, van der Woude 2015 y 2010, Nielsen 2014 y 2013, Schulze 2014, Hassid 2014, Yarur 2013, Selinger 2012, Makol 2011, Jain 2011, Zrour 2010, Van Assche 2010, Weber 2008, Heetun 2007, Østensen 2007 y 2006, Temprano 2005, Alstead 2002, Chin 2001, Janssen 200, Gran 1998, Connell 1996, Byron 1987)
List of WHO essential medicines 2002: Avoid if the Infant is premature or less than 1month old. Monitor the infant for side-effects (bloody diarrhea, haemolysis and jaundice). Avoid in G6PD deficient infants. (WHO 2002)
Mesalazine derivatives that not contain Sulfapyridine are recommended by some authors for use while breastfeeding (see alternative drugs). (Habal 2012, Mottet 2009 y 2007)
Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.
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e-lactancia is a resource recommended by Academy of Breastfeeding Medicine - 2006 of United States of America
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