Gadolinium Causing Medical Condition
The CDC report comes days after the European regulatory agency concluded that two of the agents -- gadodiamide (Omniscan) and gadoversetamide (OptiMark) -- are contraindicated in patients with advanced renal disease. The CDC report comes only weeks after the FDA warned of the possible link.
The mechanism of injury and a complete understanding of how Gadolinium-is causing and/or associated with nephrogenic fibrosing dermopathy is unknown. However, one hypothesis is that the gadolinium ions might dissociate from the chelate and result in a fibrotic reaction. In a recent study, 35 patients with this condition were identified in St. Louis, and a matched case-control study showed that only gadolinium contrast agents were independently associated with the condition. In this study, exposure to the agents increased the risk of the condition nearly nine-fold, the researchers found. In a multivariate analysis, the odds ratio was 8.97 with a 95% confidence interval from 1.28 to 63.01. This research was prompted by a cluster of nephrogenic fibrosing dermopathy among dialysis patients in a St. Louis area hospital. The investigation and review of the records found a total of 33 confirmed or suspected NSF/NFD cases between 2002 and 2006, of whom 28 had been treated at the hospital.
The findings were based on those confirmed cases, if both clinical findings, such as skin thickening or hardening, and the findings of a skin biopsy (punch or wedge) were consistent with the condition. A suspected case was one in which either clinical or biopsy findings but not both were consistent with the condition. The subsequent case-control study included 19 of the confirmed cases from the hospital, each matched with three unaffected patients who were treated in the same dialysis clinic or treatment center on the same day that a case was diagnosed.
