US FDA says cancer warnings required for TNF blockers

The U. Food and Drug Administration is requiring stronger warnings in the prescribing information for a class of drugs known as tumor necrosis factor (TNF) blockers. The warnings, which include an updated boxed warning, highlight the increased risk of cancer in children and adolescents who receive these drugs to treat juvenile rheumatoid arthritis, the inflammatory bowel disorder, Crohn's disease, and other inflammatory diseases.

In addition, the FDA says it is working with manufacturers to explore new ways to further define the risk of cancer in children and adolescents who use these drugs.

Responding to the FDA announcement, US biotechnology firm Amgen and drug major Wyeth issued a statement regarding the results of a safety review of TNF blockers [marketed as Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (golimumab)]. This safety review was the subject of an FDA Early Communication in June 2008 pertaining to cases of malignancy in pediatric patients exposed to a TNF blocker. As a result of this review, the FDA has required strengthened warnings about the occurrence of lymphoma and other cancers in children and young adults using these medicines, the two companies noted.