Marckmann P et al. (2006) Nephrogenic systemic fibrosis: suspected causative role of gadodiamide used for contrast-enhanced magnetic resonance imaging. J Am Soc Nephrol 17: 2359–2362

Nephrogenic systemic fibrosis (NSF) is a newly described, uncommon disease typically affecting middle-aged patients suffering from end-stage renal disease. The underlying etiology of this serious condition is unknown, but case studies have indicated that gadodiamide, used for contrast-enhanced MRI, might be implicated.

Marckmann and colleagues reviewed all confirmed cases of NSF (n = 13) arising in their nephrology department between August 2005 and May 2006. Each case was assessed for clinical characteristics, exposure to gadodiamide, and other potentially relevant exposures or events. The diagnosis of NSF was based on clinical course, dermatological findings and skin histology. Of the 13 patients diagnosed with NSF, 7 (54%) became severely disabled, 1 of whom died 20 months after first clinical signs developed. All patients with NSF had been exposed to contrast-enhanced MRI with gadodiamide before the development of NSF symptoms. The median time from exposure to first recorded sign of the disease was 25 days (range 2–75 days). No other exposures or events were common to more than seven patients in the 6 months before NSF onset. Gadodiamide doses used ranged from 9 mmol to 25 mmol (average 18.5 mmol), but there was no apparent association between dosage and NSF severity. The odds ratio for acquiring NSF following gadodiamide exposure was calculated as being between 32.5 (95% CI 1.9–549.2; P <0.0001) and 47.6 (95% CI 2.8–804.0).

The authors conclude that NSF seems to be related to gadodiamide exposure, and recommend that gadodiamide use be suspended until further studies have investigated this possible causal link.