FDA panel: docs don't consider adrenal suppression in kids on topical steroids: in kids with atopic dermatitis.(Dermatologic Therapy)

Publication: Skin & Allergy News

Publication Date: 01-DEC-03

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COPYRIGHT 2003 International Medical News Group

GAITHERSBURG, MD. -- Educational materials and perhaps a black box warning in the patient package insert are needed to alert physicians and parents that use of topical steroids to treat pediatric atopic dermatitis may result in asymptomatic, secondary adrenal suppression, a Food and Drug Administration advisory panel recommended.

The FDA convened the Anti-Infective Drugs Advisory Committee's pediatric subcommittee to help decide how to design a risk management program for topical corticosteroids in children with atopic dermatitis and to convey that risk to physicians, patients, and families.

Suggesting a specific risk management program would be a challenge when the precise degree of risk posed by topical corticosteroids remains vague, noted Dr. Jonathan Wilkin, director of the FDA's division of dermatologic and dental drug products, Rockville, Md.

Given the danger posed by silent adrenal suppression in children, however, it is necessary to develop both...

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