High prevalence of nephrogenic systemic fibrosis in chronic renal failure patients exposed to gadodiamide, a gadolinium-containing magnetic resonance contrast agent

Objective: Nephrogenic systemic fibrosis (NSF) is a serious disease affecting renal failure patients. It may be caused by some gadolinium (Gd)-containing contrast agents, including gadodiamide. The study aimed at estimating the prevalence of NSF after gadodiamide exposure for patients with chronic kidney disease (CKD). Materials and Methods: Retrospective cohort study of 190 consecutive nephrological patients in different categories of kidney function referred for gadodiamide-enhanced magnetic resonance imaging in the period January 1, 2004 to March 21, 2006. Results: Eighteen patients (18/190; 10%, 95% CI: 6%-15%) were diagnosed with NSF within a mean follow-up period of 29 months (range 16-43 months). All 18 cases had stage 5 CKD (ie, estimated glomerular filtration rate less than 15 mL/min/1.73 m(2) or in dialysis therapy) at the time of their gadodiamide exposure. The prevalence of NSF among patients with stage 5 CKD at exposure (n = 102) was 18% (95% CI: 11%-27%). No cases were seen among 88 gadodiamide-exposed patients who had milder degrees of renal insufficiency (prevalence 0%, 95% CI: 0%-4%). Conclusions: The risk of NSF is unacceptably high among stage 5 CKD patients exposed to gadodiamide.