FDA Notes Increase in Rare Blood Cancers Associated with TNF Blockers

The FDA reported today that tumor necrosis factor (TNF) blockers, which are anti-inflammatory drugs used to treat digestive disorders such as Crohn’s disease and ulcerative colitis, may be responsible for an increased incidence of hepatosplenic T-cell lymphoma (HSTCL) in adolescents and young adults. The FDA has updated the number of reported cases of HSTCL, a rare, usually fatal blood cancer that spreads quickly among white blood cells.

TNF blockers include such drugs as infliximab (Remicade), golimumab (Simponi), adalimumab (Humira), etanercept (Enbrel), and certolizumab pegol (Cimzia). The FDA said that HSTCL was also reported in patients taking azathioprine and mercaptopurine when used alone and in combination with the TNF blockers.

In 2009, the FDA warned of an increase in lymphomas and other types of cancer in children and adolescents using TNF blockers. Today’s FDA safety report noted that patients with Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, and ankylosing spondylitis are potentially more susceptible to lymphoma than most Americans. Therefore, the FDA noted that it “may be difficult to measure the added risk of TNF blockers, azathioprine, and/or mercaptopurine.”

The manufacturers of the TNF blockers, azathioprine, and mercaptopurine are updating their product labels to include warnings of the risk of HSTCL.