Going too far? Derms question pediatric warning for TN

Key Points

National report - Although hardly unexpected, the Food and Drug Administration's decision to add a warning about a possible link between tumor necrosis factor (TNF) antagonists and cancer in children goes too far, say most dermatologists contacted by Dermatology Times.

"I do not think a stronger warning is justified - the additional data is based on spontaneous case reports," says Joel M. Gelfand, M.D., M.S.C.E., medical director, clinical studies unit, and associate professor of dermatology at the University of Pennsylvania.

Moreover, one dermatologist says, the attention grabbed by this warning overshadows a concurrent warning about the risk of new-onset psoriasis.

TNF drug makers also must add a warning about reported cases of leukemia in adults, adolescents and children who have taken these drugs. Manufacturers also must update the products' adverse events labeling to alert users to reported cases of new-onset psoriasis, the FDA alert states.

TNF blockers include Remicade (infliximab, Centocor/Johnson & Johnson), Enbrel (etanercept, Amgen/Wyeth), Humira (adalimumab, Abbott), Cimzia (certolizumab, UCB) and Simponi (golimumab, Centocor/Johnson & Johnson).

However, the FDA says its analysis excluded malignancy reporting rates for adalimumab, certolizumab and golimumab because adalimumab and certolizumab see minimal pediatric use, while golimumab earned FDA approval in April, after the analysis occurred.

Other shoe drops

But some dermatologists say the warnings are unfounded, at least for some of the drugs.

The FDA's analysis states infliximab was the only TNF inhibitor to post consistently higher-than-expected reporting rates for lymphomas and all malignancies.

Dr. Kress says that while adalimumab, golimumab and certolizumab are too new for the FDA to determine if they raise cancer risk, "They're getting a warning, as well."

"I would rather the FDA make drug-specific warnings, not class-specific warnings," he says.