Friday, November 4, 2011 (Last Updated: 11/07/2011)
FRIDAY, Nov. 4 (HealthDay News) -- The U.S. Food and Drug Administration is stepping up their safety surveillance of tumor necrosis factor (TNF) inhibitors, such as infliximab and adalimumab, amidst ongoing reports of hepatosplenic T-cell lymphoma in children and young adults, according to a safety alert issued Nov. 4 by the agency.
Most cases of the rare but aggressive and usually fatal white blood cell cancer have been reported in patients receiving TNF inhibitors for inflammatory bowel disease, but some cases have also been reported in patients undergoing treatment for rheumatoid arthritis and psoriasis. The enhanced safety surveillance will entail in-depth follow-up by the manufacturers of the drug on reports of malignancy cases.
Physicians are asked to be vigilant for malignancy in patients being treated with TNF inhibitors and to report all cases to the FDA's MedWatch program. Information should include patient characteristics, risk factors for cancer, exposure to other immune suppressing agents, and duration and dose of TNF inhibitor.
According to the FDA, "this type of safety surveillance is important for our improved understanding of malignancies in pediatric and young adult patients treated with TNF blockers because it will allow FDA to more completely capture and analyze all reported malignancies based on more complete and consistent reports."
Hematology & Oncology
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