On June 6, 2006, and December 22, 2006, GE Healthcare issued a safety advisory for Omniscan® (gadodiamide), its gadolinium-containing contrast agent, warning physicians that the use of Omniscan contrast medium in magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA) in patients with pre-existing renal (kidney) issues may lead to that patient developing a rare and potentially devastating disease, called nephrogenic systemic fibrosis (NSF). This disease is also known as nephrogenic fibrosing dermopathy (NFD).
Omniscan® is a contrast agent commonly used by physicians in MRI and MRA; it is a colorless, non-radioactive, water-like fluid. During an MRI or MRA, gadolinium based contrast agents such as Omniscan® are injected into veins of the patient so that the physician can view a clear and detailed picture of a patient’s internal organs, bones, vessels, and/or tissue. Contrast markers bond with damaged or diseased tissues, giving doctors a clearer picture of potential problems.
GE Healthcare first launched Omniscan® in the United States in 1993. It is one of a group of five gadolinium-based injections which have been approved by the U.S. Food and Drug Administration (FDA), which also includes Magnevist®, MultiHance®, OptiMARK® and ProHance®.
NSF is an emerging systemic disorder that is characterized by widespread tissue fibrosis. It first became known to the medical community in 1997 and to date, has only been observed in patients with kidney disease. Patients with NSF experience an increase of collagen in the tissues, causing thickening and hardening of the skin of the extremities and often resulting in immobility and tightening or deforming of the joints. NSF can develop rapidly and may result in patients becoming wheelchair bound in just a few weeks. In some cases, there is involvement of other tissues, including the lungs, heart diaphragm, esophagus and skeletal muscles. In some instances NSF can lead to death. Other signs and symptoms of NSF include:
- Burning Itching Swelling
- Hardening and tightening of the skin
- Red or dark patches on the skin
- Yellow spots on the whites of the eyes
- Stiffness in joints and difficulty moving limbs
- Bone pain in the hips or ribs Muscle weakness
Studies investigating the relationship between NSF and gadolinium are currently underway at Yale, the Centers for Disease Control (CDC), the FDA and the medical regulatory agencies of the European Union. After accumulating numerous reports of NSF in patients, the FDA issued public health advisories in June and December 2006 which advised cautionary use of all gadolinium-based contrast agents in patients with moderate to advanced renal disease. Most recently, on May 23, 2007, the FDA asked manufacturers to include a new “boxed warning” on the product labeling of all gadolinium-based contrast agents. A “boxed warning” is the highest form of caution that the FDA can ask a manufacturer of a drug to give to the public. The new warning states that patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a debilitating, and a potentially fatal disease case of NSF. In addition, it states that patients – just before or just after liver transplantation – or those with chronic liver disease, are also at risk for developing NSF if they are experiencing kidney insufficiency of any severity.
There is no effective treatment available for NSF.
Our firm, and our affiliated firms are accepting cases of NSF and NFD and we would be happy to discuss any concerns you may have, if you or a loved one is suffering this devastating disease.