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.
BACKGROUND
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.


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


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


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


METHODS
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.


RESULTS
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%.


CONCLUSIONS
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.


CONCLUSIONS
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.
Kim
Kyung-Ho
KH
Renal Section, State University of New York at Stony Brook, Stony Brook, NY 11794, USA. kykkim@notes.cc.sunysb.edu
Fonda
Jennifer R
JR
Lawler
Elizabeth V
EV
Gagnon
David
D
Kaufman
James S
JS
D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D003287:Contrast Media / Q000009:adverse effects; D003404:Creatinine / Q000097:blood; D003430:Cross-Sectional Studies; D016208:Databases, Factual; D004363:Drug Utilization / Q000706:statistics & numerical data; D005260:Female; D005682:Gadolinium / Q000009:adverse effects; D005919:Glomerular Filtration Rate; D019983:Guideline Adherence / Q000706:statistics & numerical data*; D006801:Humans; D007674:Kidney Diseases / Q000097:blood / Q000503:physiopathology; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D014481:United States; D014493:United States Department of Veterans Affairs; D014486:United States Food and Drug Administration; D055815:Young Adult
D003287:Contrast Media; D005682:Gadolinium; D003404:Creatinine