Plaintiffs v Makers of Gadolinium
Gadolinium & Nephrogenic Systemic Fibrosis
Medical researchers have linked a rare disorder, Nephrogenic Fibrosing Dermopathy (NFD), also known as Nephrogenic Systemic Fibrosis (NSF), to the gadolinium contrast dyes used in MRIs (magnetic resonance imaging) and MRAs (magnetic resonance angiography). The gadolinium dyes, which are frequently used to create better contrast to assist physicians in reading the results of these tests, can be highly dangerous to patients with impaired kidney function.
NFD/NFS is a progressive disease associated with the development of excessive scar tissue and/or thick, hardened areas of skin that severely limit joint movement and prevent patients from walking or moving their hands, arms, legs and/or feet. There is no known cure for NFS/NFD, which can be fatal.
The U.S. Food and Drug Administration has requested that manufacturers of gadolinium include a boxed warning on the drug information sheet warning patients with severe kidney insufficiency about the dangers of the gadolinium-based agents. The warning states that patients who have had or are about to have liver transplants, or who have chronic liver disease, are also at risk for developing NFD/NSF if they are experiencing kidney insufficiency of any severity.
In June 2006, (and later with additional FDA Alerts in December 2006 and May 2007), the FDA issued a warning to Health Care Professionals, concerning Gadolinium Based Contrast Agents (GMCAs), used for Magnetic Resonance Imaging (MRI) and the risk of contracting Nephrogenic Systemic Fibrosis (NSF).
The first reports of patients suffering from NSF occurred in early 1996 where the Danish Health Authority began observing a number of cases of NSF. In June of 1996, the FDA after receiving 25 reported cases of NSF began to compile information on NSF from post-marketing reports.
At this time, a number of medical articles, including an article by H.L. Zhang, H. Ersoy, and M.R. Prince began to assess the general safety of GMCAs in patients with impaired renal failure.
Other authors focused on examining the casual relationship between NSF and GMCAs. Since the FDA's initial June 2006 Warning, there have been a number of recent medical articles documenting the relationship between GMCAs and NSF. See "Gadolinium-based contrast exposure, nephrogenic systemic fibrosis, and gadolinium detection in tissue".
On April 27, 2007, the International Center for Nephrogenic Fibrosing Dermopathy Research (ICNFDR) at Yale, issued a report citing to a total of 236 reported cases. On May 23, 2007, the FDA formally requested that all manufacturers of GMCAs place a Black-Box warning for contrast agents used for MRI imaging, namely that such warning should disclose that "patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a debilitating, and a potentially fatal disease known as nephrogenic systemic fibrosis (NSF)."
