Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of
Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults

AUDIENCE: Rheumatology, Gastroenterology, Oncology, Dermatology
ISSUE: FDA continues to receive reports of a rare cancer of white blood
cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL, primarily in
adolescents and young adults being treated for Crohn’s disease and ulcerative
colitis with medicines known as tumor necrosis factors (TNF) blockers, as well
as with azathioprine, and/or mercaptopurine. TNF blockers include
Remicade (infliximab), Enbrel (etancercept), Humira (adalimumab), Cimzia
(certolizumab pegol) and Simponi (golimumab).
BACKGROUND: HSTCL is an aggressive (fast-growing) cancer and is usually fatal.
The majority of cases reported were in patients being treated for Crohn’s
disease or ulcerative colitis, but also included a patient being treated for
psoriasis and two patients being treated for rheumatoid arthritis. FDA is now
updating the number of reported cases of HSTCL.
Although most reported cases of HSTCL occurred in patients treated with a
combination of medicines known to suppress the immune system, including the TNF
blockers, azathioprine, and/or mercaptopurine, there have been cases reported in
patients receiving azathioprine or mercaptopurine alone.

• Educate patients and caregivers about the signs and symptoms of malignancies
such as HSTCL so that they are aware of and can seek evaluation and treatment of any
signs or symptoms. These may include splenomegaly, hepatomegaly, abdominal pain,
persistent fever, night sweats, and weight loss.
• Monitor for the emergence of malignancies when a patient has been treated with
TNF blockers, azathioprine, and/or mercaptopurine.
• Know that people with rheumatoid arthritis, Crohn's disease, ankylosing
spondylitis, psoriatic arthritis and plaque psoriasis may be more likely to develop
lymphoma than the general U.S. population. Therefore, it may be difficult to measure
the added risk of TNF blockers, azathioprine, and/or meracaptopurine.
Read the Drug Safety Communications for other specific recommendations for Healthcare
Professionals and Patients and the Data Summary for additional information.
Healthcare professionals and patients are encouraged to report adverse events or
side effects related to the use of these products to the FDA's MedWatch Safety
Information and Adverse Event Reporting Program:
• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete
and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Fuente:  FDA  y  ANMAT



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