Used Gadolinium?

Our DC and Boston Injury Attorneys Hold Drug Companies Responsible for Your Injuries

Gadolinium is metal based dye that is injected into the bloodstream to enhance MRI and MRA images
Gadolinium can cause Nephrogenic Systemic Fibrosis (NSF) in patients with kidney problems
NSF is a debilitating, potentially fatal disease for which there is no known cure
The pharmaceutical companies knew about the life-threatening side effects as early as April 2006
The FDA ordered a black box warning in May 2007 for the labels of all gadolinium dyes

FDA Gadolinium Warning 5/23/07

In May 2007, the FDA requested that the manufacturers of the five gadolinium based contrast agents used in MRIs include a boxed warning – the FDA’s strongest possible safety warning – on product labels highlighting the risk they posed to patients with kidney problems. The FDA warned that patients who are at risk for NSF should be monitored by their doctors, and told to report any symptoms associated with the condition immediately. The FDA has also set up a reporting program so that healthcare providers can report instances of NFS caused by Gadolinium based contrast agents.

FDA Gadolinium Warning 12/22/06

In December of 2006, the FDA issued its second public health advisory regarding gadolinium based contrast dyes. At that time, the FDA said it had received 90 reports of patients with moderate to end-stage kidney disease who developed NSF after being exposed to gadolinium based contrast agents. At the time of this alert, the FDA said about 215 patients worldwide were known to have NSF. Of those whose medical history were known, all had been exposed to gadolinium contrast agents prior to diagnosis.

Gadolinium Side Effects Linked to NSF & NFD

The FDA says that people who get an MRI with gadolinium based contrast agents are at risk for NSF. Because NSF is debilitating and may cause death, the FDA urges that anyone who develops the disease undergo immediate dialysis. As of December 21, 2006, 90 patients with moderate to end-stage kidney disease are known to have developed the new disease, called nephrogenic systemic fibrosis or nephrogenic fibrosing dermopathy (NSF/NFD), after they had an MRI or MRA with a gadolinium-based contrast agent. Symptoms of NSF/NFD may appear within two days or even as long as 18 months after exposure to the contrast agent. The dosage associated with NSF/NFD can vary as well. Some patients have developed the disease after receiving only one dose of the contrast agent, while others patients who received a higher dosage also developed NSF/NFD.

Warning signs that a patient may have NSF or NFD are: 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 with trouble moving or straightening the arms, hands, legs, or feet; pain deep in the hip bones or ribs; and muscle weakness.

What is Gadolinium?

Gadolinium, a chemical element in the periodic table, is used in an MRI/MRA in order to better observe lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues. Gadolinium, which is pronounced gad•o•lin•i•um, has been shown to improve the high-temperature characteristics of iron, chromium, and related alloys, and is most notably used with magnetic resonance imaging.

Gadolinium was endorsed for use in MRI scans in 1988 and has been used in millions of studies since. The element is the preferred contrast agent for folks with chronic kidney disease, however recent finding are causing many to reconsider this preference. Gadolinium gained favor because the use of iodine-containing contrast agents is still a common cause of hospital-acquired acute renal failure and is associated with increased death & morbidity.

Gadolinium Contrast Dye is also referred to as:

Omniscan™ by GE Healthcare
OptiMARK by Mallinckrodt/Tyco Healthcare
Magnevist by Bayer/Schering AG/Berlex
ProHance by Bracco Diagnostics,
MultiHance by Bracco Diagnostics

If you, or a loved one, have been diagnosed with NSF or NFD or are experiencing any of the symptoms identified above please contact the Boston and Washington DC injury lawyers of Pollack & Flanders as soon as possible.