title: Safety and efficacy of immunomodulators and biologics during pregnancy and lactation for the treatment of inflammatory bowel disease.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: University of Wisconsin, School of Medicine and Public Health, 1685 Highland Avenue, Madison, 53705, USA.
authors.forename: Sumona
authors.initials: S
authors.lastname: Saha
authors.forename: Arnold
authors.initials: A
authors.lastname: Wald
mesh_terms: D000818:Animals; D004348:Drug Labeling; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects / Q000627:therapeutic use*; D015212:Inflammatory Bowel Diseases / Q000150:complications / Q000188:drug therapy*; D007774:Lactation; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy* / Q000503:physiopathology; D011256:Pregnancy Outcome; D012306:Risk; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D007155:Immunologic Factors