Boxed Warning Updated: TNF Blockers and Cancer Risks in Children

Last Updated on November 3, 2009 by Joseph Gut – thasso

November 3, 2009 – As we learn from it’s todays announcement, FDA is requiring stronger warnings about an increased risk of lymphoma and other cancers in children and adolescents who are treated with drugs that block tumor necrosis factor. TNF blockers include Infliximab [Remicade], Etanercept [Enbrel], Adalizumab [Humira], Certolizumab [Cimzia], and Golimumab [Simponi]. These drugs are used to treat juvenile rheumatoid arthritis, Crohn’s disease, and other inflammatory diseases.

The warnings, which include an updated boxed warning, are based on an FDA analysis of reports of cancer that occurred in children and adolescents treated with TNF-blockers. The cancers, some of which were fatal, occurred after an average of 30 months of treatment. About half of the cancers were lymphomas. The labeling will also include updated information on cases of leukemia and new onset psoriasis associated with TNF-blockers.

Healthcare professionals should monitor patients for development of malignancies during and after treatment with TNF blockers. They should also talk to patients and their families about this risk and tell them to report signs and symptoms of cancer such as unexplained weight loss or fatigue, easy bruising or bleeding, or swollen lymph nodes in the neck, underarms or groin.

Patients should also be monitored for signs or symptoms of new onset psoriasis or worsening psoriasis. The patient Medication Guide will be updated with this new information.

Additional Information: FDA MedWatch Safety Alert. Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi). August 4, 2009.

Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

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