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 informationPharmacovigilanceDiagnosing nephrogenic systemic fibrosis in the post‐FDA restriction era
Thomson LK, Thomson PC, Kingsmore DB, Blessing K, Daly CD, Cowper SE, Roditi GH. Diagnosing nephrogenic systemic fibrosis in the post‐FDA restriction era. Journal Of Magnetic Resonance Imaging 2014, 41: 1268-1271. PMID: 24903851, DOI: 10.1002/jmri.24664.Peer-Reviewed Original ResearchMeSH KeywordsAgedContrast MediaDiagnosis, DifferentialDrug ApprovalGadoliniumGadolinium DTPAHumansMagnetic Resonance ImagingMaleNephrogenic Fibrosing DermopathyPractice Guidelines as TopicUnited StatesConceptsNephrogenic systemic fibrosis
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
2012
Nephrogenic systemic fibrosis: concepts and perspectives
de Souza Machado Igreja A, de Carvalho Mesquita K, Cowper SE, Costa IM. Nephrogenic systemic fibrosis: concepts and perspectives. Anais Brasileiros De Dermatologia 2012, 87: 597-607. PMID: 22892775, DOI: 10.1590/s0365-05962012000400013.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsMeSH KeywordsContrast MediaDiagnosis, DifferentialDisease ProgressionGadoliniumHumansNephrogenic Fibrosing DermopathyPrognosisConceptsNephrogenic systemic fibrosisGadolinium-based contrast agentsSystemic fibrosisNephrogenic systemic fibrosis casesCareful clinicopathological correlationEffective preventive methodsMagnetic resonance imagingContrast agentsRenal impairmentRenal functionClinicopathological correlationSkin changesProgressive conditionFibrosis casesVisceral organsKidney disordersResonance imagingPreventive methodsPatientsFibrosisDiseaseExposureAgentsRemissionNephrologistsLinking 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
2011
Nephrogenic systemic fibrosis: Clinicopathological definition and workup recommendations
Girardi M, Kay J, Elston DM, LeBoit PE, Abu-Alfa A, Cowper SE. Nephrogenic systemic fibrosis: Clinicopathological definition and workup recommendations. Journal Of The American Academy Of Dermatology 2011, 65: 1095-1106.e7. PMID: 21724294, DOI: 10.1016/j.jaad.2010.08.041.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsDiagnosis of NSFNephrogenic systemic fibrosisClinicopathological definitionNSF diagnosisWorkup recommendationsPrior clinical experienceClinicopathological presentationRenal diseaseHistopathological featuresRisk factorsStudy populationPrecise causationSystemic fibrosisClinical experienceAccurate diagnosisClinical expertiseDiagnostic standardHistopathological atlasDiagnosisGold standardMedical investigationsCompelling associationPhysiciansIndisputable linkContrast agents
2010
Renal transplantation for nephrogenic systemic fibrosis: a case report and review of the literature
Cuffy MC, Singh M, Formica R, Simmons E, Abu Alfa AK, Carlson K, Girardi M, Cowper SE, Kulkarni S. Renal transplantation for nephrogenic systemic fibrosis: a case report and review of the literature. Nephrology Dialysis Transplantation 2010, 26: 1099-1101. PMID: 21079195, DOI: 10.1093/ndt/gfq693.Peer-Reviewed Case Reports and Technical NotesMeSH KeywordsFemaleGraft RejectionHumansKidney TransplantationMiddle AgedNephrogenic Fibrosing DermopathySkin DiseasesTreatment OutcomeConceptsNephrogenic systemic fibrosisRenal transplantationSystemic fibrosisSymptoms of NSFEarly renal transplantationUnderwent renal transplantationRare fibrosing disorderStandard therapy existsRenal functionFibrosing disorderRenal diseaseCase reportTherapy existsPatient's lesionTherapeutic modalitiesTransplantationPatientsLesionsFibrosisPhotopheresisPlasmapheresisImatinibSymptomsCareful considerationDisease
2009
Gadolinium‐containing magnetic resonance image contrast agent promotes fibrocyte differentiation
Vakil V, Sung JJ, Piecychna M, Crawford JR, Kuo P, Abu‐Alfa A, Cowper SE, Bucala R, Gomer RH. Gadolinium‐containing magnetic resonance image contrast agent promotes fibrocyte differentiation. Journal Of Magnetic Resonance Imaging 2009, 30: 1284-1288. PMID: 19937928, PMCID: PMC2787835, DOI: 10.1002/jmri.21800.Peer-Reviewed Original ResearchConceptsPeripheral blood mononuclear cellsNephrogenic systemic fibrosisSerum amyloid PFibrocyte differentiationDifferentiation of monocytesNSF patientsBlood mononuclear cellsHemodialysis patientsInterleukin-12Mononuclear cellsPurified monocytesFibroblast-like cellsFibrotic lesionsHealthy controlsSystemic fibrosisAmyloid PContrast agentsPatientsMonocytesDifferentiation inhibitorWiley-LissFibrocytesOmniscanDifferentiation protocolsCells