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.
FDA Gadolinium Warning 6/08/06
In June 2006, the Food & Drug Administration (FDA) issued what would be the first of three warnings on gadolinium contrast dyes. Following the publication of the Dutch NSF study in 2006, the FDA issued an alert to healthcare providers that gadolinium based agents had been tied to multiple cases of NSF. Although these cases were not limited to one gadolinium based contrast agent, three were most often associated with the onset of NSF. Those three were Ominiscan, Magnevist and OptiMark. At that time the FDA warned physicians to screen patients for kidney problems prior to using gadolinium based contrast agents during MRIs.
Gadolinium MRI Side Effects
Gadolinium side effects have been know to cause Nephrogenic Systemic Fibrosis (NSF) a disorder characterized by widespread tissue fibrosis. The controversy surrounding the use of gadolinium contrast dye in magnetic resonance imaging (MRI) continues to swirl, yet many people don’t know what gadolinium is or why they should be concerned. However, the data which continues to be reported about gadolinium and its uses suggests that everyone should have a strong interest in learning more about gadolinium.
Our Dedicated Lawyers and Attorneys Have Years of Experience Handling Defective Drug Lawsuits Such as Gadolinium Which is Associated With Diseases That Cause Kidney and Renal Failure Such as NSF and NFD
Gadolinium Contrast Agent MRA Side Effects
Magnetic Resonance Angiography (MRA) is a type of MRI that is used to provide pictures of blood vessels inside the body. Often gadolinium based MRI contrast agents are used to enhance these images. The use of gadolinium based MRI contrast agents for MRAs is an off-label use that has never been approved by the Food & Drug Administration (FDA). However, the use of gadolinium based MRI contrast agents in MRAs is a growing practice that is putting kidney patients at an even greater risk of developing Nephrogenic Systemic Fibrosis/ Nephrogenic Fibrosing Dermopathy (NSF/NFD) because these procedures use far more gadolinium than a typical MRI.
For gadolinium based MRI contrast agents to be effective in an MRA, they must be administered at three times the approved dose. If a person’s kidneys are not functioning properly, it is extremely unlikely that so much gadolinium will be eliminated from the body. This makes it far more likely that a patient with pre-existing kidney disease will develop NSF/NSD if exposed to gadolinium based MRI contrast agents. In fact, some of the first reports of NSF/NSD actually occurred in patients who were exposed to gadolinium based MRI contrast agents during MRAs.
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. The FDA says there are 215 patients with NSF in the world. About 75 of those people had gotten a gadolinium-based contrast agent for an MRI or MRA. The FDA adds that it has identified gadolinium in skin biopsies of patients with NSF. The agency says they are unsure why those with moderate to end-stage kidney disease who receive a gadolinium based contrast agent develop NSF. 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/NSD may appear within two days or even as long as 18 months after exposure to the contrast agent. The dosage associated with NSF/NSD 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/NSD.
Experts have warned that gadolinium based MRI scans be avoided in patients with advanced kidney disease until more is known about the true causal link between gadolinium and Nephrogenic Systemic Fibrosis (NSF).
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 Brand Names
- Omniscan™ by GE Healthcare
- OptiMARK by Mallinckrodt/Tyco Healthcare
- Magnevist by Bayer/Schering AG/Berlex
- ProHance by Bracco Diagnostics,
- MultiHance by Bracco Diagnostics
Legal Help For Victims Of Gadolinium MRI MRA Contrast Agent
If you or a loved developed NSF as a result of Gadolinium MRI Contrast Dye you have valuable legal rights. Please fill out the form at the right for a free case evaluation or call 1-800-YOURLAWYER (1-800-968-7529).