‘With great power comes great responsibility’: Boxed warnings in pediatric dermatology
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Key takeaways:
- Topical calcineurin inhibitors for the treatment of atopic dermatitis have a boxed warning for cancer.
- For patients with severe AD, the benefits of medications with boxed warnings may outweigh the risks.
MIAMI BEACH, Fla. — Pediatric dermatologists should be open with patients and families when discussing boxed warnings while emphasizing that the benefits outweigh the risks, according to a speaker here.
“When talking about black boxed warnings, I think the most important thing is context,” Peter A. Lio, MD, clinical assistant professor of dermatology and pediatrics at Northwestern University Feinberg School of Medicine, said in a presentation at Masters of Pediatric Dermatology. “And the context is a background of misery.”
Children with atopic dermatitis often suffer from extreme quality-of-life impairment that “may be greater than type 1 diabetes, if you can imagine it,” Lio said.
“We often hit a point where we need a treatment that is more powerful,” he added. “And with great power comes great responsibility.”
According to Lio, the pediatric dermatology community is no stranger to black boxed warnings. In 2005, the FDA released a black boxed warning for topical calcineurin inhibitors (TCIs), causing mass panic among families and a sharp decline in prescribing.
Since then, prescriptions have steadily risen again, but there is still some “distrust, and some fear, and some families really don’t want to use them,” Lio explained.
However, studies on TCIs — including a 10-year study with 8,000 patients, a 6-year study with about 7,500 children and a PEER study of 6,000 individuals — have concluded that “we really don’t see an increased risk of cancer in these patients,” Lio said.
Lio also referenced a study published in 2023 in The Lancet Child & Adolescent Health where the authors stated that, “Among individuals with atopic dermatitis, moderate-certainty evidence shows that topical calcineurin inhibitors do not increase the risk of cancer.”
“This is about as good as it gets,” Lio said. “So, what do I say when I’m talking about TCIs with my patients?”
Lio first recommends that clinicians be open and honest with their patients.
“If you don’t tell them about the boxed warnings and they discover it on their own, that can poison the well and they won’t want to use them at all,” he said.
After telling them about the boxed warnings, Lio suggests pointing out that the benefits outweigh the minimal risks by stating, “your eczema, right now, is worse than the possible side effects, which seem to be extremely low, maybe less or the same as the background.”
Further, TCIs are a nonsteroidal agent. By using them, children can avoid the systemic events that accompany standard topical corticosteroids.
“Once I put it that way, they feel very comfortable with it, and we are able to move forward,” Lio concluded.
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Lio PA, et al. Boxed warnings: How to address safety concerns. Presented at: Masters of Pediatric Dermatology; Feb. 8-9, 2024; Miami Beach, Florida.
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