The Basics
What is Sulfasalazine?
Sulfasalazine is a type of drug known as a disease-modifying anti-rheumatic drug (DMARD). It may be used on its own or with other drugs. Sulfasalazine changes the way your condition affects you, and reduces inflammation, pain and swelling in your joints. It can be used to treat: rheumatoid arthritis.
Brand names for Sulfasalazine
Azulfidine, Azulfidine Entabs, Sulfazine, Sulfazine Ec
How Sulfasalazine is classified
Gastrointestinal Agents, Anti-Inflammatory Agents – Non-Steroidal, Antirheumatic Agents, Sulfonamides, Antibacterial Agents, Anti-Infective Agents
Sulfasalazine During Pregnancy
Sulfasalazine 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 Sulfasalazine while pregnant
N/A
Taking Sulfasalazine While Breastfeeding
What are recommendations for lactation if you're taking Sulfasalazine?
Sulfasalazine and its active metabolite mesalamine are 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. Another sulfasalazine metabolite, sulfapyridine, also appears in milk and infant serum and might cause hemolysis, especially in newborn infants and in those with glucose-6-phosphate dehydrogenase (G6PD) deficiency. The time of greatest risk for hemolysis in fullterm newborns without G6PD deficiency might be as short as 8 days after birth.[1] Bloody diarrhea has occurred in an infant whose mother was taking sulfasalazine and a few cases of diarrhea have been reported in infants exposed to mesalamine in breastmilk, although the rate is not high. Most experts consider mesalamine derivatives to be safe during breastfeeding.[2][3][4][5][6][7] If sulfasalazine is required by the mother, it is not a reason to discontinue breastfeeding, but carefully observe breastfed infants for diarrhea. Other mesalamine derivatives that do not contain a sulfonamide are preferred.
Maternal / infant drug levels
Sulfasalazine and its active metabolite mesalamine are 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. Another sulfasalazine metabolite, sulfapyridine, also appears in milk and infant serum and might cause hemolysis, especially in newborn infants and in those with glucose-6-phosphate dehydrogenase (G6PD) deficiency. The time of greatest risk for hemolysis in fullterm newborns without G6PD deficiency might be as short as 8 days after birth.[1] Bloody diarrhea has occurred in an infant whose mother was taking sulfasalazine and a few cases of diarrhea have been reported in infants exposed to mesalamine in breastmilk, although the rate is not high. Most experts consider mesalamine derivatives to be safe during breastfeeding.[2][3][4][5][6][7] If sulfasalazine is required by the mother, it is not a reason to discontinue breastfeeding, but carefully observe breastfed infants for diarrhea. Other mesalamine derivatives that do not contain a sulfonamide are preferred.
Possible effects of Sulfasalazine on milk supply
Relevant published information was not found as of the revision date.
Possible alternatives to Sulfasalazine
(Rheumatoid Arthritis) Auranofin, Etanercept, Gold Sodium Thiomalate, Hydroxychloroquine, Infliximab, Methotrexate, Penicillamine, Sulfasalazine; (Ulcerative Colitis) Mesalamine, Olsalazine.
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. Zao J, Koren G, Bozzo P. Using nitrofurantoin while breastfeeding a newborn. Can Fam Physician. 2014;60:539-40. PMID: 24925943
2. Nielsen OH, Maxwell C, Hendel J. IBD medications during pregnancy and lactation. Nat Rev Gastroenterol Hepatol. 2014;11:116-27. PMID: 23897285
3. Mahadevan U, Matro R. Care of the pregnant patient with inflammatory bowel disease. Obstet Gynecol. 2015;126:401-12. PMID: 26241432
4. 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
5. 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
6. Flint J, Panchal S, Hurrell A et al. BSR and BHPR guideline on prescribing drugs in pregnancy and breastfeeding-Part I: standard and biologic disease modifying anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford). 2016;55:1693-7. PMID: 26750124
7. Gotestam Skorpen C, Hoeltzenbein M, Tincani A et al. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016;75:795-810. PMID: 26888948
8. Azad Khan AK, Truelove SC. Placental and mammary transfer of sulphasalazine. Br Med J. 1979;2:1553. PMID: 43760
9. Jarnerot G, Into-Malmberg MB. Sulphasalazine treatment during breast feeding. Scand J Gastroenterol. 1979;14:869-71. PMID: 44005
10. Berlin CM Jr, Yaffe SJ. Disposition of salicylazosulfapyridine (Azulfidine) and metabolites in human breast milk. Dev Pharmacol Ther. 1980;1:31-9. PMID: 6108198
11. Christensen LA, Rasmussen SN, Hansen SH et al. Salazosulfapyridine and metabolites in fetal and maternal body fluids with special reference to 5-aminosalicylic acid. Acta Obstet Gynecol Scand. 1987;66:433-5. PMID: 2892343
12. Esbjorner E, Jarnerot G, Wranne L. Sulphasalazine and sulphapyridine serum levels in children to mothers treated with sulphasalazine during pregnancy and lactation. Acta Paediatr Scand. 1987;76:137-42. PMID: 2882643
13. Branski D, Kerem E, Gross-Kieselstein E et al. Bloody diarrhea–a possible complication of sulfasalazine transferred through human breast milk. J Pediatr Gastroenterol Nutr. 1986;5:316-7. PMID: 2870147
14. Nelis GF. Diarrhoea due to 5-aminosalicylic acid in breast milk. Lancet. 1989;333:383. Letter. PMID: 2563532
15. Follmer W. Uber die anwendung sulfonamiden im wochenbett. Klin Wochenschr. 1941;20:912-3.
16. 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.
17. Correia LM, Bonilha DQ, Ramos JD et al. Inflammatory bowel disease and pregnancy: report of two cases treated with infliximab and a review of the literature. Eur J Gastroenterol Hepatol. 2010;22:1260-4. PMID: 20671559
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.
