Product Liability

Chron’s, colitis drug linked to deadly cancer

A fast-growing and deadly type of cancer has been reported in patients – in particular, adolescents and young adults – who are taking a type of medication used to treat Crohn’s disease and ulcerative colitis. The Food and Drug Administration (FDA) alerted doctors that a rare cancer of white blood cells known as Hepatosplenic T-Cell Lymphoma or HSTCL has been linked to medicines called 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).

HSTCL is an aggressive cancer that is usually fatal. The majority of cases were reported in patients being treated for Chron’s disease or ulcerative colitis, but also included a patient being treated for psoriasis and two patients being treated for rheumatoid arthritis.

The FDA is currently 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.

The FDA is recommending that patients and caregivers be educated about the signs and symptoms of malignancies such as HSTCL so they are aware of and can seek evaluation and treatment. Symptoms include abdominal pain, persistent fever, night sweats and weight loss. Patients on TNF, azathioprine and/or mercaptopurine should also be monitored for the disease. Patients on these medications who have questions should consult their doctors.

Any side effects, including the diagnosis of cancer, while taking these drugs should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.