title: Diagnosing nephrogenic systemic fibrosis in the post-FDA restriction era.
abstract: The emergence of an association between gadolinium-based contrast agents (GBCA) and the rare condition nephrogenic systemic fibrosis (NSF) led to a warning in 2006 from the Food and Drug Administration (FDA) restricting the use of the GBCAs to patients with an estimated glomerular filtration rate of >30 mL/min/1.73m(2) . We discuss our experience with a post-FDA restriction presentation of NSF and subsequent patient death in which the prolonged lead-time of ∼5.5 years led to challenges in ensuring a secure diagnosis of NSF and establishing risk exposures. Accurate contemporary records of contrast administration and clinical factors alongside clinical and pathological expertise ensured that we were able to confidently diagnose NSF, despite the length of lead time and confounding factors.
authors.affiliation: Specialty Registrar, Department of Radiology, Glasgow Royal Infirmary, Glasgow, UK.
authors.forename: Laura K
authors.initials: LK
authors.lastname: Thomson
authors.forename: Peter C
authors.initials: PC
authors.lastname: Thomson
authors.forename: David B
authors.initials: DB
authors.lastname: Kingsmore
authors.forename: Karen
authors.initials: K
authors.lastname: Blessing
authors.forename: Conal D
authors.initials: CD
authors.lastname: Daly
authors.forename: Shawn E
authors.initials: SE
authors.lastname: Cowper
authors.forename: Giles H
authors.initials: GH
authors.lastname: Roditi
mesh_terms: D000368:Aged; D003287:Contrast Media / Q000009:adverse effects; D003937:Diagnosis, Differential; D017277:Drug Approval; D005682:Gadolinium / Q000009:adverse effects; D019786:Gadolinium DTPA / Q000009:adverse effects*; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000009:adverse effects* / Q000592:standards*; D008297:Male; D054989:Nephrogenic Fibrosing Dermopathy / Q000175:diagnosis*; D017410:Practice Guidelines as Topic; D014481:United States
chemical_list: D003287:Contrast Media; C064925:gadodiamide; D005682:Gadolinium; D019786:Gadolinium DTPA
keywords: gadolinium; glomerular filtration rate; nephrogenic systemic fibrosis