FDA alters label of TNF blockers to include warnings of reported cases of leukemia in adults, adolescents and children and malignancies in children and adolescents

These cases are from various disease states and agents. We are awaiting specifics regarding each case anticipating that they will provide additional information for clinical decision making regarding the care and counseling of patients, both pediatric and adult, and their families with moderate to severe psoriasis. Meanwhile, this new warning should be addressed in context with patients on, or considering, TNF agents.

For more information on the FDA announcement:

Web Page Title: FDA: Cancer Warnings Required for TNF Blockers

Web Page URL: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm175803.htm

For more information on the FDA announcement for healthcare professionals, including a summary of the data on which it was based:

Web Page URL: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsan

Melodie S. Young, MSN, RN, ANP-c