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FDA Officials Discuss Extrapolation & Confusion Around Pediatric Therapies

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Dr. Belen said this labeling has received a great deal of consideration and may not be finalized. “We’re getting more information, and the labeling could be updated in the future.”

However, “the main consideration” was that some publications are using the DRESS nomenclature, she said. In addition, the warnings and precautions in the labeling describe cases involving hypersensitivity outside of the DRESS definition, so hypersensitivity reactions in general are covered.

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Thomas Collins is a freelance medical writer based in Florida.

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