Sulfasalazine Pregnancy and Breastfeeding Warnings

Sulfasalazine is also known as: Azulfidine, Azulfidine EN-tabs, Sulfazine

Sulfasalazine Pregnancy Warnings

Sulfasalazine has been assigned to pregnancy category B by the FDA. During animal studies using doses up to six times the normal human dose, no adverse fetal effects have been revealed. There are no controlled data in human pregnancy. Sulfasalazine is only recommended for use during pregnancy when the need has been clearly established and benefit outweighs risk.

Sulfasalazine, sulfapyridine, and other metabolites cross the placenta. In one infant, umbilical cord serum concentrations of sulfasalazine and sulfapyridine were equal to concentrations found in the maternal serum. Sulfasalazine use during pregnancy appears to be safe. A review compared 287 pregnancies in women with ulcerative colitis or Crohn's disease treated with sulfasalazine and/or steroids to 244 pregnancies in women who were not treated. Abnormalities reported in infants whose mothers who received sulfasalazine and steroids includes cleft palate, microglasia, and congenital deafness. The incidence of abnormalities was not significantly between the treated and untreated patients. The incidence of spontaneous abortion, premature birth, and low birth weight in the treated infants was less than the predicted values based on the general population. In a review of 229,101 deliveries to Michigan Medicaid patients,72 first-trimester exposures to sulfasalazine and 72 exposures any time during pregnancy were recorded. A total of two birth defects were reported with first trimester exposure and one with exposure during pregnancy. These data do not support an association to birth defects. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994) Agranulocytosis has been reported in one newborn whose mother took sulfasalazine and prednisone throughout pregnancy. Another infant whose mother was treated with sulfasalazine throughout pregnancy was born with microcephaly, ventricular septal defect and coarctation of the aorta. Cleft palate and severe hydrocephalus has also been reported in one infant.

Sulfasalazine Breastfeeding Warnings

Sulfonamides are excreted into human milk. Following oral administration, insignificant amounts of uncleaved sulfasalazine are found in breast milk. Sulfapyridine, a metabolite of sulfasalazine, has levels in milk about 30% to 60% of those in maternal serum. Sulfonamides compete with bilirubin for plasma protein binding sites and may cause kernicterus in newborns. Sulfapyridine has poor bilirubin-displacing capacity. Sulfapyridine is considered compatible with breastfeeding by the American Academy of Pediatrics if caution is exercised in infants with jaundice or G6PD deficiency, and in ill, stressed, or premature infants. One breastfed infant developed bloody diarrhea while the mother ingested sulfasalazine. The mother was determined to be a slow acetylator of sulfonamides. The diarrhea resolved 48 to 72 hours after the mother discontinued sulfasalazine. No other etiology could be found for the infant's diarrhea. Five cases (limited data) of bloody stools or diarrhea have been reported in infants fed breast milk from mothers taking sulfasalazine. In cases where outcome was reported, the infant's bloody stools or diarrhea resolved after the mother discontinued sulfasalazine or breastfeeding was discontinued. Due to limited data, a causal relationship has not been established, but cannot be ruled out. Monitoring for signs and symptoms of diarrhea and/or bloody stools in infants receiving breast milk from mothers taking sulfasalazine should be considered.

Caution is recommended. Excreted into human milk: Yes Excreted into animal milk: Unknown

See Also...

• Sulfasalazine use while Breastfeeding (in more detail)
• sulfasalazine Consumer Information
• Pregnancy Support Group
• FDA Pregnancy Categories
• Medicine use during Pregnancy
• Medicine use while Breastfeeding
• Safe Medications during Breastfeeding

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