FDA Removes Box From Inhaled Corticosteroid Adrenal Insufficiency Warning
Executive Summary
Removal of the box surrounding the inhaled corticosteroid class warning about adrenal insufficiency in labeling is justified because no cases have been reported, FDA says
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Inhaled corticosteroid advertising
GlaxoSmithKline is considering running "reminder" ads for the inhaled corticosteroid products Flovent (fluticasone) and Advair (fluticasone/salmeterol) in light of FDA removal of black box from class warning on adrenal insufficiency (1"The Pink Sheet" Feb. 4, p. 25). The warning remains in labeling and will remain in the fair balance section of product-and-use ads...