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Expert Opin Drug Saf. 2012 Nov;11(6):947-57. doi: 10.1517/14740338.2012.720970. Epub 2012 Sep 6.

Safety and efficacy of immunomodulators and biologics during pregnancy and lactation for the treatment of inflammatory bowel disease.

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University of Wisconsin, School of Medicine and Public Health, 1685 Highland Avenue, Madison, 53705, USA.



The inflammatory bowel diseases (IBD) are chronic, idiopathic, inflammatory conditions of the gastrointestinal tract, that peak in incidence during the reproductive years. Therefore, the safety of IBD medications during pregnancy and lactation is of significant interest to patients. Unfortunately, the current pregnancy labeling used by the United States Food and Drug Association (FDA) is often misinterpreted and may mislead healthcare providers and their patients to believe that risk increases from Category A to B to C to D to X, which in fact, is not the case. In addition, the FDA categories do not always distinguish between risks based on human versus animal data, or between differences in frequency, severity, and type of fetal developmental toxicities.


This article provides an in-depth review of the available safety data during pregnancy and lactation for the more potent immunosuppressants used to treat IBD: the immunomodulators and biologics. It also includes the authors' expert opinions on the use of these medications during these critical periods.


The benefit-to-risk ratio for most immunomodulators and biologics used in the treatment of IBD favors medication continuation during pregnancy. Certain immunomodulators, however, can cause extreme fetal harm and should be used with caution. While human safety data regarding teratogenesis and some data on pregnancy outcomes exist for most IBD medications, long-term follow-up studies of children and young adults exposed to these drugs in utero are lacking. These studies are needed to determine if these drugs are of sufficiently low risk to be considered safe.

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