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
Edwards BJ, Laumann AE, Nardone B, Miller FH, Restaino J, Raisch DW, McKoy JM, Hammel JA, Bhatt K, Bauer K, Samaras AT, Fisher MJ, Bull C, Saddleton E, Belknap SM, Thomsen HS, Kanal E, Cowper SE, Abu Alfa AK, West DP. 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. British Journal Of Radiology 2014, 87: 20140307. PMID: 25230161, PMCID: PMC4170864, DOI: 10.1259/bjr.20140307.Peer-Reviewed Original ResearchMeSH KeywordsContrast MediaCooperative BehaviorDatabases, FactualDrug-Related Side Effects and Adverse ReactionsGadoliniumGadolinium DTPAHeterocyclic CompoundsHumansMaleMeglumineNephrogenic Fibrosing DermopathyOrganometallic CompoundsPharmacovigilanceRegistriesUnited StatesConceptsGadolinium-based contrast agentsAdverse drug eventsDrug eventsMedicines AgencyGadopentetate dimeglumineDrug Administration Adverse Event Reporting SystemAdverse Event Reporting SystemDanish Medicines AgencyNephrogenic systemic fibrosisEvent Reporting SystemEuropean Medicines AgencyNSF casesHistopathological dataContrast agentsSystemic fibrosisDrug AdministrationLegal data setsUnconfounded casesGadobenate dimeglumineMean numberDimeglumineReporting systemPharmacovigilance researchSafety informationPharmacovigilance