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
2012
Linking Drugs to Obscure Illnesses: Lessons from Pure Red Cell Aplasia, Nephrogenic Systemic Fibrosis, and Reye’s Syndrome. A Report From the Southern Network on Adverse Reactions (SONAR)
Bennett CL, Starko KM, Thomsen HS, Cowper S, Sartor O, Macdougall IC, Qureshi ZP, Bookstaver PB, Miller AD, Norris LB, Xirasagar S, Trenery A, Lopez I, Kahn A, Murday A, Luminari S, Cournoyer D, Locatelli F, Ray P, Mattison DR. Linking Drugs to Obscure Illnesses: Lessons from Pure Red Cell Aplasia, Nephrogenic Systemic Fibrosis, and Reye’s Syndrome. A Report From the Southern Network on Adverse Reactions (SONAR). Journal Of General Internal Medicine 2012, 27: 1697-1703. PMID: 22692632, PMCID: PMC3509314, DOI: 10.1007/s11606-012-2098-1.ChaptersConceptsPure red cell aplasiaNephrogenic systemic fibrosisChronic kidney disease patientsSerious adverse drug reactionsKidney disease patientsRed cell aplasiaReye's syndromeNSF casesCell aplasiaDisease patientsSystemic fibrosisAdministration of aspirinDanish Medicines AgencyAdverse drug reactionsYears of identificationCKD patientsCounter medicationsDrug reactionsAdverse reactionsGadodiamide administrationObscure illnessPediatric useMedicines AgencyPatientsSyndrome