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Hepatosplenic T Cell Lymphoma Associated With Infliximab Use in Young Patients Treated for Inflammatory Bowel Disease

Mackey, Ann Corken; Green, Lanh; Liang, Li-ching; Dinndorf, Patricia; Avigan, Mark

Journal of Pediatric Gastroenterology & Nutrition: February 2007 - Volume 44 - Issue 2 - p 265–267
doi: 10.1097/MPG.0b013e31802f6424
Short Communications

Hepatosplenic T cell lymphoma (HSTCL) are rare cancers (≈100 published cases worldwide) and comprise 5% of peripheral T cell lymphomas. As of October 5, 2006, the FDA's Adverse Event Reporting System has received 8 cases of HSTCL in young patients using infliximab, a tumor necrosis factor-α blocking agent, to treat inflammatory bowel disease (6 of the 8 cases had a fatal outcome). All 8 patients were receiving concomitant immunosuppressant therapy (eg, azathioprine, prednisone). It has not been established that infliximab had an exclusive or primary role in the pathogenesis of these HSTCL cases; however, it appears that patients using this product may be at greater risk for developing this rare lymphoma.

Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD

Received 19 October, 2006

Accepted 17 November, 2006

Address correspondence and reprint requests to Ann Corken Mackey, RPh, MPH, Bldg 22, Room 3472, 10903 New Hampshire Ave, Silver Spring MD 20993 (e-mail:

The views expressed in this article are those solely of the authors and not necessarily those of the US Food and Drug Administration. No financial support or research assistance was received for this study.

© 2007 Lippincott Williams & Wilkins, Inc.