2014
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 ResearchConceptsGadolinium-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
2013
Pediatric nephrogenic systemic fibrosis is rarely reported: a RADAR report
Nardone B, Saddleton E, Laumann AE, Edwards BJ, Raisch DW, McKoy JM, Belknap SM, Bull C, Haryani A, Cowper SE, Abu-Alfa AK, Miller FH, Godinez-Puig V, Dharnidharka VR, West DP. Pediatric nephrogenic systemic fibrosis is rarely reported: a RADAR report. Pediatric Radiology 2013, 44: 173-180. PMID: 24057195, PMCID: PMC3946726, DOI: 10.1007/s00247-013-2795-x.Peer-Reviewed Original ResearchConceptsNephrogenic systemic fibrosisSystemic fibrosisGadolinium-based contrast agentsDrug Administration Adverse Event Reporting SystemAdverse Event Reporting SystemEvent Reporting SystemRenal functionPediatric casesResearch RegistryContrast agentsFibrosisDuplicate reportingU.S. FoodSystematic searchReported numberRegistryChildrenReporting systemFAERSExposureReportAgentsMethodsWeCases