Sulfasalazine Pregnancy and Breast Feeding Warnings
Sulfasalazine is also known as: Azulfidine, Azulfidine EN-tabs, Sulfazine
Overview
If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sulfasalazine Delayed-Release Tablets while you are pregnant. Sulfasalazine Delayed-Release Tablets is found in breast milk. If you are or will be breast-feeding while you use Sulfasalazine Delayed-Release Tablets, check with your doctor. Discuss any possible risks to your baby.
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 Lactation 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, is excreted into milk and produces concentrations which are 30% to 60% of those found in serum. Sulfonamides generally displace bilirubin from protein binding sites, resulting in the risk of kernicterus in newborns. Sulfapyridine has been found to have poor bilirubin displacing capacity. The American Academy of Pediatrics considered sulfapyridine, a metabolite of sulfasalazine, to be compatible with breast-feeding if caution is exercised in infants with jaundice or G-6-PD deficiency, and in ill, stressed, or premature infants.
One breast-fed 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 infants diarrhea.
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