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Most studies on animals do not show an increase in congenital malformations associated with sulfasalazine (Reprotox #1253).  There are case reports of human pregnancies with maternal sulfasalazine use resulting in various isolated anomalies (Connell and Miller 1999).  However, this medication has been used extensively in pregnancy with no apparent increase in the risk of miscarriage, congenital anomalies or prematurity (Connell and Miller 1999 and Mogadam et al., 1981).  The concentration of sulfasalazine in cord blood is approximately equal to that of the maternal concentration. Sulfasalazine inhibits both metabolism and transportation of folic acid.  Norgard et al., (2001) studied sulfasalazine use in pregnancy because of its effect on folate metabolism.  This study did not find an increase in any congenital malformations,       including neural tube defects, with use of this medication.  However, supplementation of 1mg twice daily of folic acid is recommended for pregnant women taking this drug (Connell and Miller 1999 and Connell and Sandborn 1999). 

5-Aminosalicylic acid

5-Aminosalicylic acid (5-ASA) was developed as an alternative to sulfasalazine.  Asacol®,   Pentosa®, Dipentum®, and Rowasa® are brand names for 5-ASA (Connell and Sandborn 1999).  Because it lacks the sulfapyridine, it does not produce the same side effects as           sulfasalazine.  5-ASA is most often used to treat acute episodes of Crohn's disease, but also to maintain remission.  It is usually well tolerated, but there are reports of occasional myocarditis, pancreatitis or renal toxicity (Connell and Miller 1999 and Connell and Sandborn 1999). 

Human data has shown that 5-ASA is found in very low concentrations in the fetus.  Overall, at therapeutic doses, 5-ASA is unlikely to produce any adverse pregnancy effects,  nor does it  appear to be associated with an increased risk of congenital malformations (Connell and Miller 1999 and Connell and Sandborn 1999).

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Current Research Studies

ITIS is currently enrolling and following up on pregnancies as part of the following studies. If you have a patient who would like to participate in one of the studies, please contact ITIS at (800) 252-4847. 

Asthma Medications in Pregnancy Project

Rheumatoid Arthritis in Pregnancy Study

Ondansetron in Pregnancy Study

Immunosuppressives

Azathioprine (Imuran®) and Mercaptopurine (Purinethol®) are purine antimetabolites used in the treatment of active Crohn's disease.  After absorption, azathioprine is metabolized to          6-mercaptopurine. These drugs are used for severely ill Crohn's patients when other drug     treatments fail (Korelitz 1990).  Patients taking these medications may experience such        complications as  reversible pancreatitis, myelotoxicity, hepatotoxicity, hypersensitivity         reactions and opportunistic infections (Connell and Miller 1999 and Korelitz 1990).  (CONTINUE)