United States Food and Drug Administration Product Label Changes
Recommended Citation
Kircik L, Sung JC, Stein Gold LF, Goldenberg G. United States Food and Drug Administration Product Label Changes. J Clin Aesthet Dermatol 2016; 9(1):39-48.
Document Type
Article
Publication Date
1-1-2016
Publication Title
J Clin Aesthet Dermatol
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.
PubMed ID
26962391
Volume
9
Issue
1
First Page
39
Last Page
48
