title: Nephrogenic systemic fibrosis and class labeling of gadolinium-based contrast agents by the Food and Drug Administration.
abstract: In 2007, the Food and Drug Administration requested that manufacturers of all approved gadolinium-based contrast agents (GBCAs), drugs widely used in magnetic resonance imaging, use nearly identical text in their product labeling to describe the risk of nephrogenic systemic fibrosis (NSF). Accumulating information about NSF risks led to revision of the labeling text for all of these drugs in 2010. The present report summarizes the basis and purpose of this class-labeling approach and describes some of the related challenges, given the evolutionary nature of the NSF risk evidence. The class-labeling approach for presentation of product risk is designed to decrease the occurrence of NSF and to enhance the safe use of GBCAs in radiologic practice.
authors.affiliation: Office of New Drugs, United States Food and Drug Administration, 10903 New Hampshire Ave, Building 22, Room 2335, Silver Spring, MD 20993, USA. Lucie.Yang@fda.hhs.gov
authors.forename: Lucie
authors.initials: L
authors.lastname: Yang
authors.forename: Ira
authors.initials: I
authors.lastname: Krefting
authors.forename: Alex
authors.initials: A
authors.lastname: Gorovets
authors.forename: Louis
authors.initials: L
authors.lastname: Marzella
authors.forename: James
authors.initials: J
authors.lastname: Kaiser
authors.forename: Robert
authors.initials: R
authors.lastname: Boucher
authors.forename: Dwaine
authors.initials: D
authors.lastname: Rieves
mesh_terms: D003287:Contrast Media / Q000009:adverse effects*; D004348:Drug Labeling; D005682:Gadolinium / Q000009:adverse effects*; D006801:Humans; D008279:Magnetic Resonance Imaging; D054989:Nephrogenic Fibrosing Dermopathy / Q000139:chemically induced* / Q000453:epidemiology / Q000517:prevention & control; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration
chemical_list: D003287:Contrast Media; D005682:Gadolinium