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Carefully scrutinized, the evidence does not support an actual malignancy risk.
The majority of these patients have chronic disease requiring long-term use of anti-inflammatory medications.
The publicity surrounding an FDA advisory released last year triggered unwarranted anxiety for a number of caregivers, followed by irrational and abrupt discontinuation of the medications and subsequent disease flares in many children.
Calcineurin inhibitors are an important therapeutic option for children with chronic, relapsing atopic dermatitis and represent the first medical breakthrough in eczema treatment since the advent of topical corticosteroids. The substantial risks of chronic corticosteroid use have been well-described, while the long-term risks with topical pimecrolimus and tacrolimus remain theoretical. Prior to availability of topical calcineurin inhibitors, coal tar was a widely used corticosteroid-sparing agent. Although topical coal tar is available without a prescription, it is unpleasant to use, minimally effective, not well-studied and has a higher theoretical potential for carcinogenesis.
Even the recommendation for the warning for Elidel, issued in February 2005, had untoward effects. The warning caused a high attrition rate in an important long-term prospective study of the drug in infants.
Further action may discourage other companies interested in studying medications in children from doing so. Additional studies must be encouraged, not discouraged, in order to accurately assess any potential risks that may exist with use of these drugs.
While we have both respect and sympathy for the FDA's difficult mission, and complications posed by recent events, media scrutiny and public perception, the addition of a black box for a speculative rather than proven adverse effect is overreaching the intended use of this warning. Acceptance of such diminished criteria for issuing black boxes will jeopardize the credibility, effectiveness and plausibility of this important cautionary mechanism. The negative consequences of this approach defeat the purpose, and will adversely affect the same patients it intends to protect.
We hope the FDA will reconsider this strategy.
Elaine Siegfried, M.D. Associate professor of pediatrics and dermatology, St. Louis University; director, Kids Dermatology, St. John's Mercy Medical Center, St. Louis.
Robert A. Silverman, M.D., F.A.A.P., F.A.A.D. President, Society for Pediatric Dermatology; clinical associate professor of pediatrics, Georgetown University Hospital, Washington.