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TNF blockers may increase the risk of malignancy in children
Date:7/29/2010

The Food and Drug Administration (FDA) received reports of malignancies in children using tumor necrosis factor a (TNF) blockers, raising concerns of an associated risk and prompting an investigation. Researchers from the FDA set out to identify all reports of malignancy in children using infliximab, etanercept, and adalimumab and their report is published in the August issue of Arthritis & Rheumatism, a journal of the American College of Rheumatology.

The FDA has approved 3 TNF blockers for use in children: Etanercept to treat juvenile idiopathic arthritis (JIA); infliximab to treat Crohn's disease; and adalimumab to treat JIA. Data suggest that certain adult populations may be at an increased risk of malignancy with TNF blocker therapy. The immunosuppressive properties of TNF blockers may also increase the risk of malignancy in children, but to what extent is unclear.

Cancer is very rare in children. According to the National Cancer Institute's Surveillance, Epidemiology, and End-Results (SEER) database, the U.S. annual incidence rate for all cancers in children ages 0󈝿 years was 16.8/100,000 compared with the rate of 469.7/100,000 for all cancers in adults, age adjusted to the year 2000 U.S. population. When 48 incidences of malignancy were identified among pediatric patients treated with TNF blockers, there was cause for concern. Study leader Peter Diak, Pharm.D., explains. "The number and rare types of malignances reported in these cases are worrisome given the underreporting of adverse events in the Adverse Event Reporting System (AERS) database, the long latency period of malignancy, and the relatively small number of pediatric patients treated with TNF blockers."

The study team searched the AERS database for all reports of malignancy in children using infliximab, etanercept, and adalimumab who initiated therapy between the ages of 0 and 18 years. The 48 cases identified included 31 following infliximab use, 15
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Contact: Dawn Peters
healthnews@wiley.com
781-388-8408
Wiley-Blackwell
Source:Eurekalert

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