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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
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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
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Date Published Title Drug Source
2009-08-04 New Boxed Warning for Tumor Necrosis Factor (TNF) Blockers Etanercept FDA
2009-08-04 New Boxed Warning for Tumor Necrosis Factor (TNF) Blockers Adalimumab FDA
2009-08-04 New Boxed Warning for Tumor Necrosis Factor (TNF) Blockers Infliximab FDA
2009-08-04 New Boxed Warning for Tumor Necrosis Factor (TNF) Blockers Certolizumab FDA
2009-08-04 New Boxed Warning for Tumor Necrosis Factor (TNF) Blockers Golimumab FDA
2009-08-02 Several Lots of Caraco Brand Allopurinol 100 mg Tablets Recalled Allopurinol FDA
2009-07-31 New Safety Information for Colchicine Colchicine FDA
2009-07-16 Omalizumab (marketed as Xolair): Early FDA Communication about an Ongoing Safety Review Omalizumab FDA
2009-07-14 FDA Requires Stronger Warnings on Some Drugs Used to Prevent Rejection of Certain Organ Transplants Sirolimus FDA
2009-07-14 FDA Requires Stronger Warnings on Some Drugs Used to Prevent Rejection of Certain Organ Transplants Cyclosporine FDA
2009-07-14 FDA Requires Stronger Warnings on Some Drugs Used to Prevent Rejection of Certain Organ Transplants Mycophenolate FDA
2009-07-14 FDA Takes Actions on Pain Medications Containing Propoxyphene FDA
2009-07-10 Recall of a Single Lot of Sotret Isotretinoin Capsules, 40 mg Isotretinoin FDA
2009-07-10 Recall of Two Lots of Citalopram: One Lot of 10 mg Tablets and One Lot of 40 mg Tablets Citalopram FDA
2009-07-07 FDA Takes Actions on Pain Medications Containing Propoxyphene Propoxyphene HCl and Acetaminophen FDA
2009-07-01 FDA Early Communication About Safety of Lantus (Insulin Glargine) Insulin Glargine FDA
2009-07-01 New Boxed Warning For Chantix (Varenicline) Varenicline FDA
2009-07-01 New Boxed Warning For Bupropion (marketed as Zyban, Wellbutrin, and generics) Bupropion FDA
2009-06-30 Early Research Results About Possible Safety Issue With Insulin Glargine (Lantus) Insulin Glargine MediGuard CRT
2009-06-25 FDA Publishes Question and Answer Guide about Acetaminophen Use Acetaminophen FDA
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