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
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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.