Guidance for Industry: Aerosol Steroid Product Safety Information in Prescription Drug Advertising and Promotional Labeling

摘要

Aerosol steroid products (i.e., inhaled corticosteroid drug products) may be used after a course of therapy with systemic steroids. Labeling for all aerosol steroid products contains a prominent boxed warning that describes the importance of switching carefully from systemic to inhaled steroids to prevent the life-threatening occurrence of adrenal insufficiency.