Safety Alerts & Recalls
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New Boxed Warning for Tumor Necrosis Factor (TNF) Blockers
The FDA is requiring the manufacturers of tumor necrosis factor (TNF) blockers to update the Boxed Warning in the prescribing information to warn of an increased risk of lymphoma and other cancers in children and adolescents treated with TNF blockers. This new Boxed Warning is an addition to the existing Boxed Warning relating to the risk of potentially fatal infections, including tuberculosis, in all patients who use TNF blockers.
The currently FDA approved TNF blockers include adalizumab (marketed as Humira), certolizumab (marketed Cimzia), etanercept (marketed Enbrel), golimumab (marketed as Simponi), and infliximab (marketed as Remicade). 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.
In addition to the updated Boxed Warning, the FDA is requiring several other changes to the prescribing information for TNF blockers, including:
1) An update to the Warnings section describing reported cases of leukemia in adults, adolescents, and children
2) An update to the Adverse Events section to include information on reported cases of new-onset psoriasis
3) An update to the Medication Guide for these medications to provide this new safety information to patients who receive prescriptions for TNF blockers
This new safety information is based on the FDA's completed analysis of TNF blockers which included reports of lymphoma and other cancers in children and adolescents, post-marketing leukemia reports in all patients, as well as a post-marketing evaluation of new-onset psoriasis in patients treated with these drugs.
For more information, please visit:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm174474.htm
Learn More
New Boxed Warning for Tumor Necrosis Factor (TNF) Blockers
The FDA is requiring the manufacturers of tumor necrosis factor (TNF) blockers to update the Boxed Warning in the prescribing information to warn of an increased risk of lymphoma and other cancers in children and adolescents treated with TNF blockers. This new Boxed Warning is an addition to the existing Boxed Warning relating to the risk of potentially fatal infections, including tuberculosis, in all patients who use TNF blockers.
The currently FDA approved TNF blockers include adalizumab (marketed as Humira), certolizumab (marketed Cimzia), etanercept (marketed Enbrel), golimumab (marketed as Simponi), and infliximab (marketed as Remicade). 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.
In addition to the updated Boxed Warning, the FDA is requiring several other changes to the prescribing information for TNF blockers, including:
1) An update to the Warnings section describing reported cases of leukemia in adults, adolescents, and children
2) An update to the Adverse Events section to include information on reported cases of new-onset psoriasis
3) An update to the Medication Guide for these medications to provide this new safety information to patients who receive prescriptions for TNF blockers
This new safety information is based on the FDA's completed analysis of TNF blockers which included reports of lymphoma and other cancers in children and adolescents, post-marketing leukemia reports in all patients, as well as a post-marketing evaluation of new-onset psoriasis in patients treated with these drugs.
For more information, please visit:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm174474.htm
Learn More