FDA Issues Public Health Advisory Concerning Gadolinium-Based Contrast Agents

In December 2006 the Food and Drug Administration (FDA) issued a second and stronger Public Health Advisory concerning a link between certain contrast agents, used during Magnetic Resonance Imaging (MRI) and Magnetic Resonance Angiography (MRA) procedures, and a debilitating and potentially fatal skin disorder known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD). Since it released its first Public Health Advisory in June 2006, the FDA has been further investigating the apparent relationship between contrast agents containing gadolinium and NSF/NFD. As of this past December, the FDA had received reports of 90 patients that developed NSF/NFD within 2 days to 18 months after after exposure to such contrast agents.

The FDA asks physicians to consider the risks of using gadolinium-based contrast agents in patients with moderate to end-stage kidney disease and advises patients to contact a doctor right away if they experience any of the symptoms of NSF/NFD.

Contact us regarding Gadolinium Contrast Agents; attorney consultations are free.

What is Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD)?

NSF/NFD occurs in individuals who have moderate to end-stage kidney disease. It is characterized by areas of tight, rigid skin and difficulty bending joints and can also result in fibrosis and the scarring of body organs. Signs of NSF/NFD also include: burning; itching; swelling; red or dark patches on the skin; difficulty moving or straightening arms, hands, legs or feet; yellow, raised spots on the whites of eyes; deep pain in the hip bones or ribs; and muscle weakness.

What is a Gadolinium-Based Contrast Agent?

An MRI is a detailed picture of a patient's internal organs and tissues, while an MRA is a used to take a detailed picture of a patient's blood vessels. During some MRI and MRA scans, a gadolinium-based contrast agent may be injected into a patient's blood vessels in order to distinguish them from other tissues. However, not all contrast agents used for this purpose contain gadolinium. The five trade names for FDA approved gadolinium-based agents are Omniscan, OptiMARK, Magnevist, ProHance and MultiHance.

Questions and Consultations

If you or someone you know suffers from moderate to end-stage kidney disease and developed NSF/NFD following an MRI or MRA, and you would like to discuss your rights, please complete our free case evaluation form. A member of Seeger Weiss LLP's experienced staff will call you to discuss your potential claim. Attorney consultations incur no obligation on your part and all initial consultations are free of charge and do not create an attorney-client relationship.

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