Boxed Warning or Boxed In? Brownstone Explains FDA Risk Labels at PDPA 2025

At the 2025 PDPA Conference, Nicholas Brownstone, MD, will take on a subject that many clinicians discuss but few have formally dissected: boxed warnings. His session, Understanding the Nature and Evidence of Boxed Warnings in Dermatology, aims to separate regulatory caution from real-world clinical risk.

“This will kind of be the first time I’m aware of that anyone’s given a formal presentation about it,” said Brownstone in a recent interview with Dermatology Times.

Boxed warnings are the FDA’s most serious alerts, but Brownstone argues they don’t always align with dermatologic evidence. “In dermatology, we have many recent medications that have boxed warnings,” he noted. “And I’m going to talk about the evidence. Is there evidence to back up these box warnings? A lot of times in dermatology, the answer is no.”

Boxed vs. Black Boxed — What’s in a Name?

One of Brownstone’s first clarifications: there is technically no such thing as a “black box warning.”
“I don’t like that term,” he said. “When you think ‘black box,’ you think of the flight recorder from a fatal plane crash. So I like to just say ‘boxed warning.’ It’s important to use that language.”

His talk will trace the history of boxed warnings, how they are determined, and how they differ internationally. For instance, Brownstone notes the European Union and Japan often omit or reword boxed warnings entirely, revealing a striking lack of global consistency.

When Class Labeling Confuses Care

Brownstone plans to highlight “class labeling,” a process where the FDA applies one warning to an entire drug class, even if supporting data varies widely. “One medication has a warning and another medication that might have very little to do with it gets the warning anyway,” he said.

He argues that this overgeneralization can lead to unnecessary patient fear, especially with newer treatments like JAK inhibitors and topical immunomodulators. “The FDA’s number 1 priority is safety,” he added. “But the unintended consequence is that it might scare some patients and providers from using the medications.”

Empowering Conversations with Patients

For Brownstone, the clinician’s role is to bring nuance back into the discussion. “I always mention it before they see it for themselves,” he explained. “I just say, ‘You may see a warning — it doesn’t apply to you. It applies to an older population with more medical issues. In my experience, people do fine.’”

This proactive approach, he said, helps reassure patients and prevents confusion once they reach the pharmacy. “You can read in a book how to give a JAK inhibitor, but it’s the experience that really counts. When you say, ‘in my experience, people do fine,’ and it’s truthful, that’s important.”

Boxed Warnings: Evidence and Evolution

Brownstone will close by offering recommendations for FDA reform, including adding levels of evidence to package inserts and improving clarity in risk language. His session promises to equip attendees with not only context but also confidence, arming clinicians with the rationale to interpret warnings critically and communicate them compassionately.

For dermatology PAs and physicians alike, this session is a chance to examine one of medicine’s most visible and misunderstood regulatory tools through an evidence-based lens.