When a patient undergoes a MRI or MRA, the Gadolinium contrast agent is usually injected into the bloodstream and is stored in blood vessels and abnormal tissue so that any problems are more visible to doctors.
Until recently, it was thought that once Gadolinium is chelated the element is relatively safe for MRI use:. In its "free" state, the element is highly toxic but when it is chelated, the water solubility of Gadolinium is increased and toxicity is reduced. Gadolinium chelates are excreted through the kidneys. In patients with poor kidney function (and even in some patients with normal kidney function) the gadolinium chelates are not excreted from the body fast enough, causing chelates to breakdown and the "free" Gadolinium gets into the body—and that can lead to Nephrogenic System Fibrosis (NSF). This disease is a progressive and potentially fatal condition associated with the hardening and thickening of the skin, severely restricting movement.
Not all contrast agents are made equal: although all gadolinium contrast agents may contribute to, and even cause NSF, some may be less risky than others, due to the way in which the coating elements, called ligands, are attached to the Gadolinium.
One report indicates the Prohance brand of Gadolinium, which is manufactured by Bracco Diagnostics, is more stable than and clears more completely than the Omniscan brand of Gadolinium (most Gadolinium lawsuits involve Omniscan). The body can break down the chemical structure of Omniscan easier than Prohance. Allegedly, GE Healthcare knew about this problem because it included extra chelating agent in with the Omniscan contrast agent in an attempt to reduce the chance of free gadolinium3+ (which is very toxic) to remain behind in the system. The same report states that Omniscan contains 48 times more excess chelate content than Prohance, and that Optimark has added nearly 120 times more excess chelate than Prohance—but even Prohance is allegedly linked to NSF.
Gadolinium contrast agent lawsuits are increasing as more patients have developed NFS. Lawsuits have been filed against the following:
Bayer Schering Pharma, Berlin, Germany, manufactures Magnevist;
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OptiMARK is manufactured by Mallinckrodt, Inc., Hazelwood, Mo.;
ProHance and Multihance, made by Bracco Diagnostics Inc., Princeton, N.J.
Bayer has recently settled some lawsuits involving Magnevist: According to Bloomberg.com, the drug company faced 241 lawsuits over its Gadolinium contrast agent and the company confirmed that it had entered into settlement discussions for about 40 of those.
By December 2008 more than 350 NSF lawsuits had been filed in federal and state courts throughout the US alleging that Gadolinium contrast agent manufacturers failed to adequately test their products and that they knew about the association to NSF/NFD for years, but failed to warn consumers.