DOI: 10.1148/radiol.2473072101
(Radiology 2008;247:915-916.)
© RSNA, 2008
Nephrogenic Systemic Fibrosis in Japan: Advisability of Keeping the Administered Dose as Low as Possible
Yoshito Tsushima, MD,
Ayako Takahashi-Taketomi, MD, and
Keigo Endo, MD
Department of Diagnostic Radiology and Nuclear Medicine, Gunma University Hospital, 3-39-15 Showa-machi, Maebashi, Gunma 371-8511, Japan
e-mail: yoshito{at}xa2.so-net.ne.jp
Editor:
Dr Kanal and colleagues (1) published an important opinion concerning nephrogenic systemic fibrosis (NSF) in the January 2008 issue of Radiology. Information on the current situation of NSF in Japan might give clues as to the possible risk factors and cause of NSF: At this time, only five NSF cases associated with gadodiamide (Omniscan; Daiichi Sankyo, Tokyo, Japan) have been reported, and no cases of NSF have been reported with other gadolinium-based contrast agents (GBCAs) (gadopentetate dimeglumine [Magnevist; Bayer Yakuhin, Osaka, Japan], gadoteridol [ProHance; Eisai, Tokyo, Japan], and gadoterate meglumine [Magnescope; Terumo, Tokyo, Japan]). In Japan, the number of GBCA doses administered is approximately 1 500 000 per year (1% of the population), and there are 250 000 hemodialysis patients. Deo et al (2) estimated the incidence of NSF in renal impaired patients exposed to GBCAs to be 2.4% per examination; thus, if 1% of hemodialysis patients undergo contrast material–enhanced magnetic resonance (MR) imaging, there should be approximately 60 cases of NSF per year. However, at this point, the number of NSF cases reported in Japan has been far smaller.
We suggest that the small number of reported cases of NSF in Japan compared to the United States and Europe can be attributed to two factors: (a) In Japan, high-dose (>0.2 mmol/kg weight) administration of GBCAs is extremely uncommon. According to reports from the United States and Europe (3,4), high-dose administration was common in both NSF and non-NSF cases. In addition, contrast-enhanced MR angiography, which usually needs a relatively large amount of GBCAs, is less commonly performed in Japan. (b) By June 2006, in the United States and Europe an official announcement had been made about NSF and its possible association with GBCAs, but in Japan the first such announcements made by the vendors of GBCAs were in April 2007. However, underdiagnosis of NSF is unlikely to explain the numerical discrepancy of NSF incidence. The Japanese experience supports the theory that the high-dose administration of GBCAs may be a risk factor for developing NSF (5), and the recommendation of the European Society of Urogenital Radiology (6) is appropriate: "In patients with CKD [chronic kidney disease stage] 4 and 5 (<30 mL/min), always use the smallest possible amount of the contrast agent to archive an adequate diagnostic examination, and never use more than 0.3 mmol/kg of Gd-CM [gadolinium-based contrast medium]."
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References
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- Kanal E, Broome DR, Martin DR, Thomsen HS. Response to the FDA's May 23, 2007, nephrogenic systemic fibrosis update. Radiology 2008;246:11–14.[CrossRef][Medline]
- 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;2:264–267.[Abstract/Free Full Text]
- Collidge TA, Thomson PC, Mark PB, et al. Gadolinium-enhanced MR imaging and nephrogenic systemic fibrosis: retrospective study of a renal replacement therapy cohort. Radiology 2007;245:168–175.[Abstract/Free Full Text]
- 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.[Abstract/Free Full Text]
- Broome DR, Girguis MS, Baron PW, Cottrell AC, Kjellin I, Kirk GA. Gadodiamide-associated nephrogenic systemic fibrosis: why radiologists should be concerned. AJR Am J Roentgenol 2007;188:586–592.[Abstract/Free Full Text]
- ESUR guideline: gadolinium based contrast media and nephrogenic systemic fibrosis. European Society of Urogenital Radiology (ESUR) Web site.http://www.esur.org/Nephrogenic_Fibrosis.39.0.html. Accessed November 12 2007.
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