American Journal of Kidney Diseases

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


      Exposure to gadolinium in patients with kidney disease has been linked to risk of developing nephrogenic systemic fibrosis. The US Food and Drug Administration (FDA) has issued warnings against the use of gadolinium in this population. We studied the impact of these warnings on the use of gadolinium-enhanced magnetic resonance (GE-MR) studies in patients with decreased estimated glomerular filtration rate (eGFR) and the practice of measuring serum creatinine before gadolinium exposure.

      Study Design

      Cross-sectional study of patients who had undergone MR studies from October 2002 to September 2008.

      Setting & Participants

      Patients receiving medical care in the US Department of Veterans Affairs Health Care System.


      Date of MR imaging, serum creatinine level, and eGFR using the 4-variable Modification of Diet in Renal Disease (MDRD) Study equation.

      Outcomes & Measurements

      The rate of MR studies performed with and without gadolinium from July 2005 to September 2008 in patients with different stages of kidney disease, defined using eGFR. The proportion of GE-MR studies with a screening serum creatinine level.


      There was a 71% decrease in the rate of GE-MR use in patients with GFR <30 mL/min/1.73 m2 2 years after the release of the first public health advisory, although studies continued to be performed in patients with stages 4 and 5 chronic kidney disease. The proportion of GE-MR studies with serum creatinine measured within 1 month before the study increased by 99%.


      Data available up to September 30, 2008. Indications for the GE-MR studies were not assessed. The accuracy of Current Procedural Terminology and International Classification of Diseases, Ninth Revision coding was not assessed.


      There was a large decrease in the use of GE-MR studies in patients with GFR <30 mL/min/1.73 m2 and a large but not universal increase in the practice of measuring serum creatinine before GE-MR after the release of the FDA warnings.

      Index Words

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to American Journal of Kidney Diseases
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Cowper S.
        • Robin H.
        • Steinberg S.
        • Su L.
        • Gupta S.
        • Leboit P.
        Scleromyxoedema-like cutaneous diseases in renal-dialysis patients.
        Lancet. 2000; 356: 1000-1001
        • Cowper S.
        • Su L.
        • Bhawan J.
        • Robin H.
        • Leboit P.
        Nephrogenic fibrosing dermopathy.
        Am J Dermatopathol. 2001; 23: 383-393
        • 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: 563-572
        • Grobner T.
        Gadolinium—a specific trigger for the development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis?.
        Nephrol Dial Transplant. 2006; 21: 1104-1108
        • 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: 2359-2362
        • US Food and Drug Administration
        Public health advisory: gadolinium-containing contrast agents for magnetic resonance imaging (MRI): Omniscan, OptiMARK, Magnevist, ProHance, and MultiHance.
        (Accessed June 22, 2009)
        • US Food and Drug Administration
        Public health advisory: update on magnetic resonance imaging (MRI) containing gadolinium and nephrogenic fibrosing dermapathy.
        (Accessed June 22, 2009)
        • 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).
        (Accessed June 22, 2009)
        • Thomsen H.S.
        • Almen T.
        • Morcos S.K.
        • 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: 2600-2605
        • 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: 180-188
        • Levey A.S.
        • Green T.
        • Kusek J.W.
        • Beck G.L.
        • MDRD Study Group
        A simplified equation to predict glomerular filtration rate from serum creatinine.
        J Am Soc Nephrol. 2000; 11 ([abstract A0848]): 155A
        • Marckmann P.
        Nephrogenic systemic fibrosis: epidemiology update.
        Curr Opin Nephrol Hypertens. 2008; 17: 315-319
        • Collidge T.A.
        • Thompson P.C.
        • Mark P.B.
        • et al.
        Gadolinium-enhanced MR imaging and nephrogenic systemic fibrosis: retrospective study of a renal replacement therapy cohort.
        Radiology. 2007; 245: 168-175
        • Deo A.
        • Fogel M.
        • Cowper S.E.
        Nephrogenic systemic fibrosis: a population study examining the relationship of disease development to gadolinium exposure.
        Clin J Am Soc Nephrol. 2007; 2: 264-267
        • Broome D.R.
        • Girguis M.S.
        • Baron P.W.
        • et al.
        Gadodiamide-associated nephrogenic systemic fibrosis: why radiologists should be concerned.
        AJR Am J Roentgenol. 2007; 188: 586-592
        • The Danish Medicines Agency
        Investigation of the safety of MRI contrast medium Omniscan.
        (Accessed June 22, 2009)
        • Ryadahl C.
        • Thomsen H.S.
        • 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: 141-144
        • 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.
        Mayo Clin Proc. 2007; 82 ([letter]): 516-522
        • US Food and Drug Administration
        FDA public health advisory: suicidality in children and adolescents being treated with antidepressant medications.
        (Accessed June 22, 2009)
        • Rosack J.
        New data show declines in antidepressant prescribing.
        Psychiatric News. 2005; 40 ([serial online]) (Accessed June 22, 2009): 1-7
        • Thomsen H.S.
        • European Society of Urogenital Radiology (ESUR)
        ESUR guideline: gadolinium-based contrast media and nephrogenic systemic fibrosis.
        Eur Radiol. 2007; 17: 2692-2696
        • Tippins R.
        • Torres W.
        • Baumgartner B.
        • Baumgarten D.
        Are screening serum creatinine levels necessary prior to outpatient CT examinations?.
        Radiology. 2000; 216: 481-484
        • 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: 734-740
        • Kanal E.
        • Barkovitch J.
        • Bell C.
        • et al.
        ACR guidance document for safe MR practices: 2007.
        AJR Am J Roentgenol. 2007; 188: 1447-1474