OTC Acne Treatment Labels Should Add Sensitivity Test Direction-FDA

摘要

FDA encourages manufacturers of OTC topical acne treatments containing benzoyl peroxide or salicylic acid to add sensitivity testing directions to labels after determining that use of the products "can cause rare but serious and potentially life-threatening allergic reactions or severe irritation." In a June 25 drug safety communication, FDA said that after working through information in adverse-event reports it received, it has not determined if serious hypersensitivity reactions were triggered by the acne products' active ingredients, inactive ingredients or a combination of both.