Safety of infliximab and other biologic agents in the inflammatory bowel diseases

The introduction of agents blocking the biologic action of tumor necrosis factor-alpha has revolutionized the treatment of Crohn's disease mid other chronic inflammatory disorders. Evaluating the safety of these agents can be challenging because of the nature of the underlying diseases for which they are used and because of concomitant administration of other medications, which may also result in adverse events. Serious infections, demyelinating disorders, lymphomas, and new-onset or worsening of existing heart failure have been found to be more common in infliximab-treated patients compared with controls. Other adverse events noted include hepatotoxicity, production of autoantibodies, lupus-like syndrome, and various cytopenias. The limited data available on safety of tumor necrosis factor-alpha inhibitors during pregnancy suggest that pregnancy outcomes in women who receive these agents is similar to that expected in the general population.