The US Food and Drug Administration (FDA) has received additional reports of a rare type of cancer—hepatosplenic T-cell lymphoma—primarily among adolescents and young adults who are being treated for Crohn’s disease or ulcerative colitis with medications known as tumor necrosis factor (TNF) blockers as well as azathioprine and/or mercaptopurine. TNF blockers include Remicade® (infliximab), Enbrel® (etanercept), Humira® (adalimumab), Cimzia® (certolizumab pegol), and Simponi® (golimumab).

Hepatosplenic T-cell lymphoma (HSTCL) is an uncommon but aggressive cancer of white blood cells. The reports of HSTCL received by the FDA have mainly involved patients being treated for Crohn’s disease or ulcerative colitis, but there has been one report involving a patient treated for psoriasis and two reports involving patients treated for rheumatoid arthritis.

Most of the reported cases involve patients who received a combination of drugs that suppress the immune system, such as TNF blockers, azathioprine, and/or mercaptopurine. There have, however, been cases reported in patients treated with azathioprine or mercaptopurine alone.

Signs and symptoms of HSTCL include enlargement of the liver or spleen, abdominal pain, persistent fever, night sweats, and weight loss. Patients who notice these or other signs or symptoms should discuss them with their physician.

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The FDA notes that patients should not stop taking TNF blockers, azathioprine, or mercaptopurine without talking to their physician.

Reference: US Food and Drug Administration. FDA Drug Safety Communication: Safety Review update on reports of Hepatosplenic T-Cell Lymphoma in adolescents and young adults receiving tumor necrosis factor (TNF) blockers, azathioprine and/or mercaptopurine. April 14, 2011.

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