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 Research
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 StatementsConceptsNephrogenic 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
2008
Gadolinium – is it to blame?
Cowper SE. Gadolinium – is it to blame? Journal Of Cutaneous Pathology 2008, 35: 520-522. PMID: 18399814, DOI: 10.1111/j.1600-0560.2008.01027.x.Commentaries, Editorials and LettersClinical and histological findings in nephrogenic systemic fibrosis
Cowper SE, Rabach M, Girardi M. Clinical and histological findings in nephrogenic systemic fibrosis. European Journal Of Radiology 2008, 66: 191-199. PMID: 18325705, DOI: 10.1016/j.ejrad.2008.01.016.Peer-Reviewed Original ResearchNSF: WHAT WE KNOW AND WHAT WE NEED TO KNOW: Nephrogenic Systemic Fibrosis: Early Recognition and Treatment
Knopp EA, Cowper SE. NSF: WHAT WE KNOW AND WHAT WE NEED TO KNOW: Nephrogenic Systemic Fibrosis: Early Recognition and Treatment. Seminars In Dialysis 2008, 21: 123-128. PMID: 18226008, DOI: 10.1111/j.1525-139x.2007.00399.x.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsNephrogenic systemic fibrosisGadolinium-containing contrast agentsEarly recognitionSystemic fibrosisAcute kidney diseaseSignificant risk factorsInvolved extremityRenal dysfunctionRenal insufficiencyExtracorporeal photopheresisRenal functionMedical therapyMuscle weaknessKidney diseaseRisk factorsDistressing diseaseEarly treatmentPhysical therapyEffective treatmentEarly symptomsEarly signsPatientsBeneficial effectsFibrosisTherapyNephrogenic Systemic Fibrosis: An Overview
Cowper SE. Nephrogenic Systemic Fibrosis: An Overview. Journal Of The American College Of Radiology 2008, 5: 23-28. PMID: 18180005, DOI: 10.1016/j.jacr.2007.08.013.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus Statements
2007
Nephrogenic systemic fibrosis and gadolinium exposure: Association and lessons for idiopathic fibrosing disorders
Cowper SE, Kuo PH, Bucala R. Nephrogenic systemic fibrosis and gadolinium exposure: Association and lessons for idiopathic fibrosing disorders. Arthritis & Rheumatism 2007, 56: 3173-3175. PMID: 17907160, DOI: 10.1002/art.22926.Commentaries, Editorials and LettersNephrogenic Systemic Fibrosis: A Population Study Examining the Relationship of Disease Development to Gadolinium Exposure
Deo A, Fogel M, Cowper SE. Nephrogenic Systemic Fibrosis: A Population Study Examining the Relationship of Disease Development to Gadolinium Exposure. Clinical Journal Of The American Society Of Nephrology 2007, 2: 264-267. PMID: 17699423, DOI: 10.2215/cjn.03921106.Peer-Reviewed Original ResearchConceptsNephrogenic systemic fibrosisGadolinium-containing contrast agentsGadolinium exposureIncidence of NSFSevere renal failurePopulation of patientsMajor risk factorOccurrence of NSFDevastating complicationESRD populationRenal failureSignificant morbidityRadiologic studiesRisk factorsSystemic fibrosisPopulation studiesESRDPatientsDisease developmentRecent reportsExposureContrast agentsRiskMorbidityComplicationsGadolinium-based MR Contrast Agents and Nephrogenic Systemic Fibrosis1
Kuo PH, Kanal E, Abu-Alfa AK, Cowper SE. Gadolinium-based MR Contrast Agents and Nephrogenic Systemic Fibrosis1. Radiology 2007, 242: 647-9. PMID: 17213364, DOI: 10.1148/radiol.2423061640.Commentaries, Editorials and LettersNephrogenic Systemic Fibrosis: A Review and Exploration of the Role of Gadolinium
Cowper SE. Nephrogenic Systemic Fibrosis: A Review and Exploration of the Role of Gadolinium. Advances In Dermatology 2007, 23: 131-154. PMID: 18159899, DOI: 10.1016/j.yadr.2007.07.002.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus Statements
2006
Gadolinium is detectable within the tissue of patients with nephrogenic systemic fibrosis
High WA, Ayers RA, Chandler J, Zito G, Cowper SE. Gadolinium is detectable within the tissue of patients with nephrogenic systemic fibrosis. Journal Of The American Academy Of Dermatology 2006, 56: 21-26. PMID: 17097388, DOI: 10.1016/j.jaad.2006.10.047.Peer-Reviewed Original ResearchConceptsNephrogenic systemic fibrosisNSF patientsSystemic fibrosisGadolinium-containing contrast materialSubset of patientsSoft tissueNumber of patientsPilot investigationTissues of patientsGadolinium-based contrastGadolinium-containing contrast agentsParaffin-embedded specimenNegative controlRenal insufficiencyDevelopment of diseasePathophysiologic mechanismsUnknown etiologyEpidemiologic associationPatientsContrast materialTissue residence timeSingle histological sectionTissue specimensBlocks of tissueDetection of gadolinium