Gadodiamide is a gadolinium based contrast agent used in MR imaging procedures to assist in the visualization of blood vessels. It is commonly marketed under the trade name Omniscan.
Gadodiamide is a contrast medium for cranial and spinal magnetic resonance imaging (MRI) and for general MRI of the body after intravenous administration. The product provides contrast enhancement and facilitates visualisation of abnormal structures or lesions in various parts of the body including the CNS.
In February 2008 Danish media stated that gadolinium based agents may be associated with a toxic reaction known as nephrogenic systemic fibrosis (NSF) in some patients with severe kidney problems.
Some articles suggested that over 60 persons examined with Omniscan had either died or had been severely disabled as a result of the use of the product. However a recent report by the Danish Medicines Agency stated that there were 35 cases of NSF reported after use of Omniscan and that 33 of these had been reported from a single centre in Copenhagen.
Nephrogenic systemic fibrosis (NSF) is a rare, but potentially serious, acquired systemic disease. To date, it has only been reported in patients with either severe, end stage or acute renal impairment. There have been no reports of NSF associated with gadolinium based contrast agents [GBCA] in those patients with mild or moderate renal impairment or with normal kidney function. This latter group of patients make up the significant majority of the population who undergo imaging procedures. To date, over 120 million doses of GBCA have been given over a 20 year period. Of those, more than 40 million doses were Omniscan.
One of the many, as yet unanswered, questions regarding NSF is why certain centres have relatively high numbers of NSF reports whereas the majority of hospitals using gadolinium contrast agents have no reports.