FDA Orders Black Box Warning Added to MRI Contrast Agent, Gadolinium Label
May 23, 2007 — The FDA ordered all gadolinium contrast agent manufacturers to add a black box warning to Gadolinium’s label, stating that patients with kidney problems or renal failure are at risk of developing Nephrogenic Systemic Fibrosis (NSF), also known as Nephrogenic Fibrosing Dermopathy (NFD). Additionally, the FDA warned patients with chronic liver disease and liver transplant patients that they have a substantial risk of developing NSF if they experience kidney problems or renal failure. The FDA announced that it will continue investigating the connection between gadolinium and NSF.
In May 2006, the Danish Medicines Agency first reported the connection between gadolinium and NSF after they studied twenty-five patients who developed NSF within three months of being injected with a gadolinium contrast agent. Subsequently, a Yale University study found that 95% of patients with NSF had undergone an MRI with a gadolinium contrast agent. The Massachusetts General Hospital reported that patients with kidney problems, who had an MRI with gadolinium, were ten times more likely to develop NSF.
Contrast Agents Involved
The FDA warning applies to the five approved gadolinium contrast agents (Omniscan, Magnevist, OptiMARK, ProHance, and Multihance). The reports do not specify which of the five FDA approved gadolinium contrast agents cause NSF. When identified, Omniscan was most frequently the contrast agent identified as causing NSF.
What is Gadolinium?
Gadolinium is an element found in some contrast agents used by doctors when performing an MRI. The gadolinium allows doctors to more clearly see defective tissue during an MRI. Gadolinium contrast agents are also used by doctors when performing an MRA (magnetic resonance angiography). The FDA does not approve the use of gadolinium contrast agents during an MRA because an MRA requires three times the approved dosage of gadolinium used in an MRI.
What is NSF?
NSF is only found in patients with pre-existing kidney problems or those with mild to moderate kidney function loss. NSF creates an excessive tissue formation in the skin and internal organs. This leads to a build-up of thick and hard skin that severely restricts movement and bending of joints. In severely affected patients, NSF may cause the inability to walk and restrict the patient to a wheelchair. Although NSF is not by itself typically fatal, it can contribute to death by restricting breathing and mobility.
Contact our Gadolinium Injury Attorneys today.
If you or a loved one has received an MRI or MRA that used a gadolinium contrast agent and suffered from NSF, you may be entitled to compensation for your injuries. Please contact one of our gadolinium contrast agent attorneys today for a confidential and free case evaluation.
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