How safe is infliximab therapy during pregnancy and lactation in inflammatory bowel disease?

INTRODUCTION: Infliximab has been approved for the treatment of patients with inflammatory bowel diseases (IBD). However, data regarding its safety during pregnancy and breastfeeding are scarce. AREAS COVERED: Relevant papers sourced from bibliographical searches (MEDLINE) up to June 2014 are reviewed. Infliximab, as adalimumab, crosses the placenta from the end of the second trimester. The use of anti-TNF agents after the second trimester leads to intrauterine exposure. Although infliximab during pregnancy in IBD patients seems to be safe in the short-term, there are concerns about the consequences of the early exposition with this drug for the development of the newborn immune system. Accordingly, it has recently been suggested that anti-TNF drugs should be stopped during, at least, the second trimester, when the mother is in remission; this approach seems to be safe for the mother and minimizes fetal exposition to the drug. Infliximab has been detected in breast milk in miniscule amounts. Case reports do not suggest toxicity; however, the effects of exposure on the neonate merit further investigation. EXPERT OPINION: Infliximab appears to be safe for the mother with IBD and the newborn, at least in the short-term. Infliximab is transferred in breast milk; although its toxicity is unlikely, it cannot be discounted without further long-term data.