The FDA issued a warning today directed to physicians including rheumatologists, gastroenterologists, oncologists, and dermatologists regarding a recent link between Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) and an increased risk of lymphoma and other cancers in children and adolescents. This new safety information is now being added as part of the drugs’ risk profile and has been given the strongest warning possible: the Boxed Warning. The 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 or label for TNF blockers does not specifically mention leukemia. TNF blockers are approved for the treatment of one or more of a number of immune system diseases including juvenile idiopathic arthritis (JIA), rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn’s disease, and ankylosing spondylitis.
Read the complete MedWatch 2009 Safety summary, including links to the Information for Healthcare Professionals sheet with recommendations for providers and for patients, and data summaries for the lymphoma, leukemia and psoriasis analyses, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm175843.htm