| ADALIMUMAB | FDA | 2009-8-31 | ADALIMUMAB-FDA-2009-8-31 | 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.
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�(TM)s disease, and ankylosing spondylitis.
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| ADALIMUMAB | Health Canada | 2009-8-20 | ADALIMUMAB-Health Canada-2009-8-20 | OTTAWA - Health Canada is informing health care professionals and Canadians that it is working with manufacturers to further strengthen product labelling for the class of drugs known as tumour necrosis factor (TNF) blockers with respect to an increased risk of cancer in children and young adults.
This communication comes in light of similar labelling updates undertaken by the U.S. FDA following their review, which concluded that there is an increased risk of lymphoma and other cancers associated with the use of TNF blocker drugs in children and adolescents.
Health Canada has also been reviewing this issue and is currently working with the manufacturers to strengthen existing warnings in the prescribing information for these drugs.
TNF blockers are used to treat patients with chronic inflammatory diseases including juvenile idiopathic arthritis (JIA), rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn's disease, and ankylosing spondylitis (a type of arthritis).
They suppress the activity of tumour necrosis factor, a protein that, when overproduced in the body, can cause inflammation and damage to bones, cartilage and tissue, and lead to immune system-related diseases.
Currently the labels for all TNF blockers include warnings and precautions on the risk of lymphomas and other cancers.
The labels will be updated to highlight the risk of specific cancers, particularly in the younger patient groups.
As well, the label updates will include other new safety information based on reviews conducted by Health Canada, including the risk of new-onset psoriasis in patients treated with TNF blockers.
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| ADALIMUMAB | FDA | 2009-8-4 | ADALIMUMAB-FDA-2009-8-4 | 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.
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�(TM)s disease, and ankylosing spondylitis.
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| ADALIMUMAB | FDA | 2008-9-4 | ADALIMUMAB-FDA-2008-9-4 | FDA notified healthcare professionals that pulmonary and disseminated histoplasmosis, coccidioidomycosis, blastomycosis and other opportunistic infections are not consistently recognized in patients taking tumor necrosis factor-α blockers (TNF blockers).
This has resulted in delays in appropriate treatment, sometimes resulting in death.
For patients taking TNF blockers who present with signs and symptoms of possible systemic fungal infection, such as fever, malaise, weight loss, sweats, cough, dypsnea, and/or pulmonary infiltrates, or other serious systemic illness with or without concomitant shock, healthcare professionals should ascertain if patients live in or have traveled to areas of endemic mycoses.
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| ADALIMUMAB | FDA | 2008-9-4 | ADALIMUMAB-FDA-2008-9-4 | FDA issued an Early Communication About an Ongoing Safety Review to inform healthcare professionals that the Agency is investigating a possible association between the use of Tumor Necrosis Factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults.
FDA is investigating approximately 30 reports of cancer in children and young adults.
These reports were submitted to FDA's Adverse Event Reporting System over a ten-year interval, beginning in 1998 through April 29, 2008.
These reports describe cancer occurring in children and young adults who began taking TNF blockers (along with other immuno-suppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine), when they were ages 18 or less, to treat juvenile idiopathic arthritis, Crohn's disease or other diseases.
Approximately half of the cancers were lymphomas, including both Hodgkin's and non-Hodgkin's lymphoma.
Long-term studies are necessary to provide definitive answers about whether TNF blockers increase the occurrence of cancers in children because cancers may take a long time to develop and may not be detected in short-term studies.
Until the evaluation is completed, healthcare providers, parents, and caregivers should be aware of the possible risk of lymphoma and other cancers in children and young adults when deciding how to best treat these patients.
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