The Food and Drug Administration (FDA) is requiring a group of popular arthritis drugs to include stronger warning of the increased risk of lymphoma and other cancers in children and adolescents treated with the medication. The warning, which follows an analysis by the FDA of tumor necrosis factor (TNF) blockers, will now be added to the black box warning currently on the products.
The new safety information will add the warning of the occurrence of leukemia and new-onset psoriasis in patients treated with TNF blockers to the current black box warning on TNF blockers. Those medications currently contain a warning for malignancies but does not specifically mention leukemia. The FDA also is requiring the manufacturers of TNF blockers to update the current Medication Guide to help patients understand the risks associated with TNF blocker therapy.
TNF blockers are a new class of arthritis drugs first approved by the FDA in 1998. The black box warning includes five drugs from Abbott Laboratories, Johnson & Johnson, and a drug co-marketed by Amgen Inc. and Wyeth. The drugs are prescribed to children with juvenile idiopathic arthritis (JIA), rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, inflammatory bowel disorder and Crohn’s disease.
The FDA urges both healthcare professionals and patients to report side effects from the use of TNF blockers to the FDA’s MedWatch Adverse Event Reporting program.