FDA MedWatch

Tumor Necrosis Factor Blockers (Remicade, Enbrel, Humira, Cimzia, Simponi):Supplemental Q&As added (increased risk of lymphoma associated with the use in children and adolescents)

Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) Updated

Audience: Rheumatologists, gastroenterologists, oncologists, dermatologists

UPDATE FROM ORIGINAL POST 08/04/2009: Supplemental Q&As added.

09/01/2009 - FDA notified healthcare professionals that it has completed its analysis of tumor necrosis factor (TNF) blockers and has concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents. This new safety information is now being added to the Boxed Warning for these products. FDA has also identified new safety information related to the occurrence of leukemia and new-onset psoriasis in patients treated with TNF blockers. The current prescribing information for TNF blockers does contain a warning for malignancies, but does not specifically mention leukemia. FDA is also requiring updates to the current Medication Guide to help patients understand the risks associated with TNF blocker therapy.

Read the complete MedWatch 2009 Safety summary including the Update of Q&A's that provide supplemental information to the original August 4, 2009 safety alert, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/ucm175843.htm