title: Advancing pharmacovigilance through academic-legal collaboration: the case of gadolinium-based contrast agents and nephrogenic systemic fibrosis-a Research on Adverse Drug Events and Reports (RADAR) report.
abstract: OBJECTIVE
  To compare and contrast three databases, that is, The International Centre for Nephrogenic Systemic Fibrosis Registry (ICNSFR), the Food and Drug Administration Adverse Event Reporting System (FAERS) and a legal data set, through pharmacovigilance and to evaluate international nephrogenic systemic fibrosis (NSF) safety efforts.
  
  
  METHODS
  The Research on Adverse Drug events And Reports methodology was used for assessment-the FAERS (through June 2009), ICNSFR and the legal data set (January 2002 to December 2010). Safety information was obtained from the European Medicines Agency, the Danish Medicine Agency and the Food and Drug Administration.
  
  
  RESULTS
  The FAERS encompassed the largest number (n = 1395) of NSF reports. The ICNSFR contained the most complete (n = 335, 100%) histopathological data. A total of 382 individual biopsy-proven, product-specific NSF cases were analysed from the legal data set. 76.2% (291/382) identified exposure to gadodiamide, of which 67.7% (197/291) were unconfounded. Additionally, 40.1% (153/382) of cases involved gadopentetate dimeglumine, of which 48.4% (74/153) were unconfounded, while gadoversetamide was identified in 7.3% (28/382) of which 28.6% (8/28) were unconfounded. Some cases involved gadobenate dimeglumine or gadoteridol, 5.8% (22/382), all of which were confounded. The mean number of exposures to gadolinium-based contrast agents (GBCAs) was gadodiamide (3), gadopentetate dimeglumine (5) and gadoversetamide (2). Of the 279 unconfounded cases, all involved a linear-structured GBCA. 205 (73.5%) were a non-ionic GBCA while 74 (26.5%) were an ionic GBCA.
  
  
  CONCLUSIONS
  Clinical and legal databases exhibit unique characteristics that prove complementary in safety evaluations. Use of the legal data set allowed the identification of the most commonly implicated GBCA.
  
  
  CONCLUSIONS
  This article is the first to demonstrate explicitly the utility of a legal data set to pharmacovigilance research.
authors.affiliation: 1 Department of General Internal Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: B J
authors.initials: BJ
authors.lastname: Edwards
authors.forename: A E
authors.initials: AE
authors.lastname: Laumann
authors.forename: B
authors.initials: B
authors.lastname: Nardone
authors.forename: F H
authors.initials: FH
authors.lastname: Miller
authors.forename: J
authors.initials: J
authors.lastname: Restaino
authors.forename: D W
authors.initials: DW
authors.lastname: Raisch
authors.forename: J M
authors.initials: JM
authors.lastname: McKoy
authors.forename: J A
authors.initials: JA
authors.lastname: Hammel
authors.forename: K
authors.initials: K
authors.lastname: Bhatt
authors.forename: K
authors.initials: K
authors.lastname: Bauer
authors.forename: A T
authors.initials: AT
authors.lastname: Samaras
authors.forename: M J
authors.initials: MJ
authors.lastname: Fisher
authors.forename: C
authors.initials: C
authors.lastname: Bull
authors.forename: E
authors.initials: E
authors.lastname: Saddleton
authors.forename: S M
authors.initials: SM
authors.lastname: Belknap
authors.forename: H S
authors.initials: HS
authors.lastname: Thomsen
authors.forename: E
authors.initials: E
authors.lastname: Kanal
authors.forename: S E
authors.initials: SE
authors.lastname: Cowper
authors.forename: A K
authors.initials: AK
authors.lastname: Abu Alfa
authors.forename: D P
authors.initials: DP
authors.lastname: West
mesh_terms: D003287:Contrast Media / Q000009:adverse effects*; D003299:Cooperative Behavior; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions; D005682:Gadolinium / Q000009:adverse effects*; D019786:Gadolinium DTPA / Q000009:adverse effects; D006571:Heterocyclic Compounds; D006801:Humans; D008297:Male; D008536:Meglumine / Q000009:adverse effects / Q000031:analogs & derivatives; D054989:Nephrogenic Fibrosing Dermopathy / Q000139:chemically induced*; D009942:Organometallic Compounds / Q000009:adverse effects; D060735:Pharmacovigilance; D012042:Registries; D014481:United States
chemical_list: D003287:Contrast Media; D006571:Heterocyclic Compounds; D009942:Organometallic Compounds; C062402:gadoteridol; C064572:gadobenic acid; D008536:Meglumine; C064925:gadodiamide; D005682:Gadolinium; D019786:Gadolinium DTPA; C112666:gadoversetamide