A patient who received multiple doses of the gadolinium contrast agent ProHance has developed nephrogenic systemic fibrosis, according to Bracco, the agent’s manufacturer.
A patient who received multiple doses of the gadolinium contrast agent ProHance has developed nephrogenic systemic fibrosis, according to Bracco, the agent's manufacturer.According to a letter dated June 28, Bracco said it had recently been made aware of a case of the severe skin disease in a dialysis patient with stage 5 chronic kidney disease who received six injections of 32 mL ProHance within two years. The patient developed NSF about six months after the last administration, according to the letter, which was provided by a radiologist to Diagnostic Imaging on August 22.
In the letter, Bracco also acknowledged receiving reports already made public:
The report of the dialysis patient with six ProHance injections has important implications in the assessment of risks for various contrast agents.
Some experts have suggested that transmetallation -- the breaking of the bond between the toxic metal gadolinium and the ligand (or chelate), the part of the contrast agent that is supposed to block the escape of the free gadolinium ion -- is more likely to occur with linear agents than with cyclic agents. The new case cited by Bracco suggests that even if cyclic agents are more resistant to transmetallation, they may still result in NSF and caution is advised for patients at risk. In this case, the patient received a large amount of gadolinium in a short period of time. "This one case will have a major impact," said Dr. Phillip H. Kuo, an assistant clinical professor of radiology at Yale University. "It confirms what we have acting upon from the start -- that essentially the only way to ensure you don't cause NSF is to avoid giving gadolinium contrast agents to patients on dialysis or with severe kidney disease."In high-risk patients, radiologists are best advised to use alternatives to contrast-enhanced imaging if possible, he said.For more information from the Diagnostic Imaging archives:
NSF prompts some experts to draw lines between contrast agents
FDA requests "black box" warning on gadolinium contrast packaging
Deadly disease shadows MRI contrast exams
New ACR guidelines warn against Omniscan MR contrast use in patients with any kidney disease
European authorities warn against use of Omniscan in at-risk patients