Kircik Leon, Sung Julie C, Stein-Gold Linda, Goldenberg Gary
Mount Sinai Medical Center, New York, New York; Indiana University School of Medicine, Indianapolis, Indiana; Physicians Skin Care PLLC, Louisville, Kentucky.
The Icahn School of Medicine at Mount Sinai, Department of Dermatology, New York, New York.
J Clin Aesthet Dermatol. 2017 Feb;10(2):20-29. Epub 2017 Feb 1.
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.
一旦一种药物获得美国食品药品监督管理局批准并上市，食品药品监督管理局会通过更改产品标签来传达新的安全信息。这些标签更改大多是在向药品生产公司或食品药品监督管理局的药品不良事件监测计划自发报告之后发生的。因此，每年会发生400至500次标签更改。光化性角化病的治疗方法体现了药物上市后整个过程中标签更改的普遍性。双氯芬酸凝胶、5-氟尿嘧啶乳膏、咪喹莫特和鬼臼毒素是光化性角化病治疗方法的例子，它们都至少经历了一次标签修订。在当前这种导致大量标签更改的自发报告系统下，每次发生标签更改并不一定意味着药物安全性发生了根本性变化。
