Safety of anti-TNF agents during pregnancy and breastfeeding in women with inflammatory bowel disease

Am J Gastroenterol. 2013 Sep;108(9):1426-38. doi: 10.1038/ajg.2013.171. Epub 2013 Jun 11.


Objectives: Anti-tumor necrosis factor (TNF) drugs are an effective therapeutic option in patients with inflammatory bowel disease (IBD). However, data regarding their safety during pregnancy and breastfeeding are scarce. The aim of this study was to critically review available data on the safety of anti-TNF therapy during pregnancy and breastfeeding in women with IBD.

Methods: Bibliographical searches (MEDLINE) up to January 2013.

Results: The studies included provided data from 462 women with IBD exposed to anti-TNF agents during pregnancy. Although these drugs cross the placenta from the end of the second trimester, they are low-risk in the short term. The use of anti-TNF agents after the second trimester leads to intra-uterine exposure. An increase in infections has recently been observed in infants exposed to immunomodulators plus anti-TNF drugs in utero, thus raising concerns about the consequences for the development of the immune system. Accordingly, it has recently been suggested that anti-TNF drugs should be stopped during the second trimester. Certolizumab is a Fab fragment of an anti-TNF monoclonal antibody, and, therefore, it may not be necessary to stop it during pregnancy. Anti-TNF drugs have been detected in breast milk, although in miniscule amounts. Case reports do not suggest toxicity; however, the effects of exposure on the neonate merit further investigation.

Conclusions: Anti-TNF drugs can cross the placenta from the latter part of the second trimester of gestation, although they seem to be safe, at least in the short term. Miniscule amounts of anti-TNF drugs are transferred in breast milk; therefore, a deleterious effect of this exposure on the neonate, although unlikely, cannot be excluded.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Antibodies, Monoclonal / adverse effects*
  • Antibodies, Monoclonal / therapeutic use
  • Breast Feeding*
  • Female
  • Humans
  • Immunoglobulin Fab Fragments / adverse effects*
  • Immunoglobulin Fab Fragments / therapeutic use
  • Immunologic Factors / adverse effects*
  • Immunologic Factors / therapeutic use
  • Inflammatory Bowel Diseases / drug therapy*
  • Pregnancy
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors*


  • Antibodies, Monoclonal
  • Immunoglobulin Fab Fragments
  • Immunologic Factors
  • Tumor Necrosis Factor-alpha