American Journal of Kidney Diseases
Volume 56, Issue 3 , Pages 427-430 , September 2010

Nephrogenic Systemic Fibrosis and Gadolinium-Enhanced Magnetic Resonance Imaging: Does a US Food and Drug Administration Alert Influence Practice Patterns in CKD?

  • Diego R. Martin, MD, PhD

      Affiliations

    • Corresponding Author InformationAddress correspondence to Diego R. Martin, MD, PhD, Department of Radiology, Emory University School of Medicine, Clinic Bldg A-AT622, 1365 Clifton Rd NE, Atlanta, GA 30322

References 

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  2. Cowper SE, Su LD, Bhawan J, Robin HS, LeBoit PE. Nephrogenic fibrosing dermopathy. Am J Dermatopathol. 2001;23(5):383–393
  3. Cowper SE. Nephrogenic fibrosing dermopathy: the first 6 years. Curr Opin Rheumatol. 2003;15(6):785–790
  4. Thomsen HS. Nephrogenic systemic fibrosis: a serious late adverse reaction to gadodiamide. Eur Radiol. 2006;16(12):2619–2621
  5. Grobner T. Gadolinium—a specific trigger for the development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis?. Nephrol Dial Transplant. 2006;21(4):1104–1108
  6. High WA, Ayers RA, Chandler J, Zito G, Cowper SE. Gadolinium is detectable within the tissues of patients with nephrogenic systemic fibrosis. J Am Acad Dermatol. 2007;56(1):21–26
  7. US Food and Drug Administration. Questions and answers on gadolinium-based contrast agents. www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htmAccessed June 29, 2010
  8. US Food and Drug Administration. Information for healthcare professionals gadolinium-based contrast agents for magnetic resonance imaging (marketed as Magnevist, MultiHance, Omniscan, OptiMARK, ProHance). Update May 23, 2007 http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142884.htmAccessed June 29, 2010
  9. US Food and Drug Administration. FDA Requests Boxed Warning for Contrast Agents Used to Improve MRI Images. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108919.htmAccessed June 29, 2010
  10. US Food and Drug Administration Center for Drug Evaluation and Research. Transcript of Joint Cardiovascular and Renal Drugs and Drug Safety and Risk Management Advisory Committees meeting. December 8, 2009;http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/UCM197768.pdfAccessed June 1, 2010
  11. Kim K-H, Fonda JR, Lawler EV, Gagnon D, Kaufman JS. Change in use of gadolinium-enhanced mangetic resonance studies in kidney disease patients after US Food and Drug Administration warnings: a cross-sectional study of veterans affairs health care system data from 2005-2008. Am J Kidney Dis. 2010;56(3):458–467
  12. Broome DR. Nephrogenic systemic fibrosis associated with gadolinium based contrast agents: a summary of the medical literature reporting. Eur J Radiol. 2008;66(2):230–234
  13. Martin DR, Semelka RC, Chapman AB, et al. Nephrogenic systemic fibrosis versus contrast induced nephropathy: risks and benefits of contrast-enhanced MR and CT in renally impaired patients. J Magn Reson Imaging. 2009;30(6):1350–1356
  14. Kanal E, Broome DR, Martin DR, Thomsen HS. Response to the FDA's May 23, 2007, nephrogenic systemic fibrosis update. Radiology. 2008;246(1):11–14
  15. Pietsch H, Lengsfeld P, Jost G, Frenzel T, Hutter J, Sieber MA. Long-term retention of gadolinium in the skin of rodents following the administration of gadolinium-based contrast agents. Eur Radiol. 2009;19(6):1417–1424
  16. Martin DR, Kalb B, Salman K, et al. Decreased incidence of NSF in patients on dialysis after changing gadolinium contrast-enhanced MRI protocols. J Magn Reson Imaging. 2010;31(2):440–446
  17. Prince MR, Zhang H, Morris M, et al. Incidence of nephrogenic systemic fibrosis at two large medical centers. Radiology. 2008;248(3):807–816

PII: S0272-6386(10)01045-0

doi: 10.1053/j.ajkd.2010.07.001

American Journal of Kidney Diseases
Volume 56, Issue 3 , Pages 427-430 , September 2010