American Journal of Kidney Diseases
Volume 56, Issue 3 , Pages 458-467 , September 2010

Change in Use of Gadolinium-Enhanced Magnetic 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

  • Kyung-Ho Kim, MD

      Affiliations

    • Renal Section, State University of New York at Stony Brook, Stony Brook, NY
    • Corresponding Author InformationAddress correspondence to Kyung-Ho Kim, MD, Renal Section, State University of New York, Stony Brook, NY 11794
    • ,
  • Jennifer R. Fonda, MA

      Affiliations

    • Massachusetts Veterans Epidemiology and Research Information Center, Department of Veterans Affairs Cooperative Study Program, VA Boston Healthcare System, Boston, MA
    • ,
  • Elizabeth V. Lawler, DSc, MPH

      Affiliations

    • Massachusetts Veterans Epidemiology and Research Information Center, Department of Veterans Affairs Cooperative Study Program, VA Boston Healthcare System, Boston, MA
    • Harvard Medical School, Boston, MA
    • ,
  • David Gagnon, MD, MPH, PhD

      Affiliations

    • Massachusetts Veterans Epidemiology and Research Information Center, Department of Veterans Affairs Cooperative Study Program, VA Boston Healthcare System, Boston, MA
    • Department of Biostatistics, Boston University School of Public Health, Boston, MA
    • ,
  • James S. Kaufman, MD

      Affiliations

    • Renal Section, VA Boston Healthcare System and Boston University School of Medicine, Boston, MA

Received 17 September 2009 ,Accepted 23 March 2010.

References 

  1. Cowper S, Robin H, Steinberg S, Su L, Gupta S, Leboit P. Scleromyxoedema-like cutaneous diseases in renal-dialysis patients. Lancet. 2000;356(9234):1000–1001
  2. Cowper S, Su L, Bhawan J, Robin H, Leboit P. Nephrogenic fibrosing dermopathy. Am J Dermatopathol. 2001;23(5):383–393
  3. Swartz R, Crofford L, Phan S, Ike R, Su L. Nephrogenic fibrosing dermopathy: a novel cutaneous fibrosis disorder in patients with renal failure. Am J Med. 2003;114(7):563–572
  4. 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
  5. Marckmann P, Skov L, Rossen K, et al. Nephrogenic systemic fibrosis: suspected causative role of gadodiamide used for contrast-enhanced magnetic resonance imaging. J Am Soc Nephrol. 2006;17(9):2359–2362
  6. US Food and Drug Administration. Public health advisory: gadolinium-containing contrast agents for magnetic resonance imaging (MRI): Omniscan, OptiMARK, Magnevist, ProHance, and MultiHance. http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053112.htmAccessed June 22, 2009
  7. US Food and Drug Administration. Public health advisory: update on magnetic resonance imaging (MRI) containing gadolinium and nephrogenic fibrosing dermapathy. http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm124344.htmAccessed June 22, 2009
  8. US Food and Drug Administration. Information for healthcare professionals: gadolinium based-contrast agents for magnetic resonance imaging (marketed as Magnevist, MultiHance, Omniscan, OptiMARK and ProHance). http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142884.htmAccessed June 22, 2009
  9. Thomsen HS, Almen T, Morcos SK, et al. Members of Contrast Media Safety Committee of European Society of Urogenital Radiology Gadolinium-containing contrast media for radiographic examinations: a position paper. Eur Radiol. 2002;12(10):2600–2605
  10. Coresh J, Byrd-Holt D, Astor B, et al. Chronic kidney disease awareness, prevalence, and trends among US adults, 1999-2000. J Am Soc Nephrol. 2005;16(1):180–188
  11. Levey AS, Green T, Kusek JW, Beck GL MDRD Study Group. A simplified equation to predict glomerular filtration rate from serum creatinine. [abstract A0848] J Am Soc Nephrol. 2000;11:155A
  12. Marckmann P. Nephrogenic systemic fibrosis: epidemiology update. Curr Opin Nephrol Hypertens. 2008;17(3):315–319
  13. Collidge TA, Thompson PC, Mark PB, et al. Gadolinium-enhanced MR imaging and nephrogenic systemic fibrosis: retrospective study of a renal replacement therapy cohort. Radiology. 2007;245(1):168–175
  14. Deo A, Fogel M, Cowper SE. Nephrogenic systemic fibrosis: a population study examining the relationship of disease development to gadolinium exposure. Clin J Am Soc Nephrol. 2007;2(2):264–267
  15. Broome DR, Girguis MS, Baron PW, et al. Gadodiamide-associated nephrogenic systemic fibrosis: why radiologists should be concerned. AJR Am J Roentgenol. 2007;188(2):586–592
  16. The Danish Medicines Agency. Investigation of the safety of MRI contrast medium Omniscan. http://www.dkma.dk/1024/visUKLSArtikel.asp?artikelID=8931Accessed June 22, 2009
  17. Ryadahl C, Thomsen HS, Marckmann P. High prevalence of nephrogenic systemic fibrosis in chronic renal failure patients exposed to gadodiamide, a gadolinium-containing magnetic resonance contrast agent. Invest Radiol. 2008;43(2):141–144
  18. Lineberry T, Bostwick M, Beebe T, Decker P. Impact of the FDA black box warning on physician antidepressant prescribing and practice patterns: opening the Pandora's suicide box. [letter] Mayo Clin Proc. 2007;82(4):516–522
  19. US Food and Drug Administration. FDA public health advisory: suicidality in children and adolescents being treated with antidepressant medications. http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm096273.htmAccessed June 22, 2009
  20. Rosack J. New data show declines in antidepressant prescribing. Psychiatric News. 2005;40:1–7[serial online] http://pn.psychiatryonline.org/cgi/content/full/40/17/1-aAccessed June 22, 2009
  21. Thomsen HS European Society of Urogenital Radiology (ESUR). ESUR guideline: gadolinium-based contrast media and nephrogenic systemic fibrosis. Eur Radiol. 2007;17(10):2692–2696
  22. Tippins R, Torres W, Baumgartner B, Baumgarten D. Are screening serum creatinine levels necessary prior to outpatient CT examinations?. Radiology. 2000;216(2):481–484
  23. Duszak R, Blackham W, Kusiak G, Majchrzak J. CPT coding by interventional radiologists: a multi-institutional evaluation of accuracy and its economic implications. J Am Coll Radiol. 2004;1(10):734–740
  24. Kanal E, Barkovitch J, Bell C, et al. ACR guidance document for safe MR practices: 2007. AJR Am J Roentgenol. 2007;188(6):1447–1474

 Originally published online as doi:10.1053/j.ajkd.2010.03.027 on June 28, 2010.

 Because an author of this manuscript is an editor for AJKD, the peer-review and decision-making processes were handled entirely by an Associate Editor (Jeffrey Fink, MD, MS, University of Maryland) who served as Acting Editor-in-Chief. Details of the journal's procedures for potential editor conflicts are given in the Editorial Policies section of the AJKD website.

PII: S0272-6386(10)00799-7

doi: 10.1053/j.ajkd.2010.03.027

American Journal of Kidney Diseases
Volume 56, Issue 3 , Pages 458-467 , September 2010

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