Certain Arthritis, Crohn's Drugs May Raise Kids' Cancer Risk: FDA

Agency strengthens 'black box' warning on medicines such as Enbrel, Remicade

By Steven Reinberg
HealthDay Reporter

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TUESDAY, Aug. 4 (HealthDay News) -- Drugs widely used to fight rheumatoid arthritis, Crohn's disease and other inflammatory disorders must now carry an updated "black box" warning label cautioning patients and doctors that the medicines may boost cancer risk in children and adolescents, the U.S. Food and Drug Administration announced Tuesday.

The drugs, called tumor necrosis factor (TNF) blockers, work by interrupting a protein that causes inflammation and damage to bones, cartilage and other tissue. They include Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (golimumab).

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"FDA announced that it has completed its analysis of TNF blockers and has concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents," according to FDA spokeswomen Crystal Rice.

"This new safety information is now being added to the boxed warning for these products," she said.

TNF blockers already carry FDA-mandated warning labels for other potential safety issues, including fungal infections. Tuesday's announcement follows on the agency's move last year to review several dozen reports of children who developed cancer while taking the medications. That investigation started in June 2008. The analysis took into account a number of reports of cancers in children treated with these drugs. The malignancies tended to arise about 30 months after starting on the medications.

About half of the cancers were lymphomas and some of the children died, according to the FDA.

The issue gained more prominence in July 2008 when doctors reporting in the New England Journal of Medicine outlined the case of a woman with Crohn's disease who took a TNF blocker and then developed lung cancer. When she ceased using the drug, her cancer disappeared.

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