title: United States Food and Drug Administration Product Label Changes.
abstract: Once a drug has been approved by the United States Food and Drug Administration and is on the market, the Food and Drug Administration communicates new safety information through product label changes. Most of these label changes occur after a spontaneous report to either the drug manufacturing companies or the Food and Drug Administration MedWatch program. As a result, 400 to 500 label changes occur every year. Actinic keratosis treatments exemplify the commonality of label changes throughout the postmarket course of a drug. Diclofenac gel, 5-fluorouracil cream, imiquimod, and ingenol mebutate are examples of actinic keratosis treatments that have all undergone at least one label revision. With the current system of spontaneous reports leading to numerous label changes, each occurrence does not necessarily signify a radical change in the safety of a drug.
authors.affiliation: Mount Sinai Medical Center, New York, New York; Indiana University School of Medicine, Indianapolis, Indiana; Physicians Skin Care PLLC, Louisville, Kentucky.
authors.forename: Leon
authors.initials: L
authors.lastname: Kircik
authors.affiliation: The Icahn School of Medicine at Mount Sinai, Department of Dermatology, New York, New York.
authors.forename: Julie C
authors.initials: JC
authors.lastname: Sung
authors.affiliation: Department of Dermatology, Henry Ford Medical Center, Detroit, Michigan.
authors.forename: Linda
authors.initials: L
authors.lastname: Stein-Gold
authors.affiliation: The Icahn School of Medicine at Mount Sinai, Department of Dermatology, New York, New York.
authors.forename: Gary
authors.initials: G
authors.lastname: Goldenberg