Gadolinium Contrast Dye Risks Can be Reduced Through ScreeningFeb 5, 2009 | Parker Waichman LLP
A new study has found that clinicians can reduce the chances that kidney patients exposed to gadolinium contrast dyes will develop Nephrogenic Systemic Fibrosis (NSF) if they screen patients for risk factors of the disease. The study, which was conducted at the Johns Hopkins University School of Medicine in Baltimore, found that the implementation of policies regarding the use of gadolinium contrast dyes in patients with severe renal dysfunction resulted in reducing the incidence of NSF.
NSF is a devastating condition that affects people with pre-existing kidney problems. There is currently no cure for NSF and no one understands its specific cause. The disorder is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death.
A growing mountain of evidence has linked NSF to gadolinium contrast dyes used in MRI and MRA studies, and it is theorized that people with kidney problems may not be able to quickly eliminate gadolinium from their body. In September 2007, the Food & Drug Administration (FDA) asked the manufacturers of gadolinium contrast dyes to add a black box warning to the product labels about its association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents. Since then, hundreds of NSF victims and their families have filed lawsuits in state and federal courts against the makers of gadolinium contrast dyes for their injuries.
The Johns Hopkins study, which is published in the February issue of the journal Radiology, involved 33 patients diagnosed with NSF from 2003 to 2008. All had previously undergone MRI or an angiographic procedure using a gadolinium contrast dye, and all had severe kidney failure at the time of exposure.
According to the study, the mean time between gadolinium injection and onset of the disease was 29 days. Between 2003 and 2006, the overall incidence of NSF was 36.5 cases per 100,000 gadolinium-enhanced MRI procedures.
After the FDA issued its 2006 gadolinium warning, Johns Hopkins implemented new policies regarding the administration of the contrast dyes in patients with kidney failure. According to the researchers, the rate of NSF fell in 2007 and 2008 to four cases per 100,000 procedures.
The researchers concluded that common risk factors for developing NSF after gadolinium exposure were acute and severe chronic kidney failure and liver or kidney transplantation. The also found that screening procedures performed before exposure to gadolinium to determine which patients were at risk of developing NSF appear to reduce the incidence of NSF. Finally, the study authors wrote that their findings further support the belief that NSF is associated with the administration of gadolinium contrast dyes.