FDA Launches Safety Review of TNF Inhibitors in Children
The U.S. Food and Drug Administration released an early communication regarding a plan to investigate a possible association between TNF inhibitor therapy and cancer in children receiving these agents for treatment of juvenile idiopathic arthritis (JIA) and Crohn’s disease. The agency plans to investigate the 30 reports of cancers in children and young adults that have been gathered over a 10 year period through the FDA’s Adverse Event Reporting System (AERS).
In addition, the FDA will collect and analyze any additional cases collected by the manufacturers. Importantly, clinical trial data used to approve the agents in children did not demonstrate a safety signal for an increased risk of cancer and the use of TNF inhibitors in children has not being restricted pending the results of the investigation.
