TNF blockers and hepatosplenic T-cell lymphoma linked

May 1, 2011

FDA has received reports of hepatosplenic T-cell lymphoma in adolescents and young adults with Crohn's disease and ulcerative colitis being treated with tumor necrosis factor blockers, azathioprine, and mercaptopurine.

FDA has received reports of hepatosplenic T-cell lymphoma (HSTCL), a rare, aggressive cancer of white blood cells that usually is fatal, in adolescents and young adults with Crohn's disease and ulcerative colitis being treated with tumor necrosis factor (TNF) blockers (ie, infliximab, etanercept, adalimumab, certolizumab pegol, and golimumab), azathioprine, and mercaptopurine.

Several cases have occurred in patients being treated for rheumatoid arthritis and in 1 patient with psoriasis.

Although HSTCL was reported most often in those patients receiving a combination of medicines that suppress the immune system, including the TNF blockers, azathioprine, and/or mercaptopurine, there were some reports of HSTCL in patients who received azathioprine or mercaptopurine as monotherapies.