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MRI contrast dyes containing gadolinium may pose risk to patients of serious injury.
Investigation Source
- Nationwide
Investigation Scope
Category Information
Product or Service
- MRI Contrast Dyes Containing Gadolinium
Injury Types
- Death
- Nephrogenic Fibrosing Dermopathy (NFD)
- Nephrogenic Systemic Fibrosis (NSF)
- Kidney Failure
Investigation Details
Investigation into gadolinium-based agents are Omniscan, OptiMARK, Magnevist, ProHance and MultiHance.
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 December 2006 the FDA had received reports of 90 patients that developed NSF/NFD within 2 days to 18 months after exposure to such contrast agents.
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.
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.
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 December 2006 the FDA had received reports of 90 patients that developed NSF/NFD within 2 days to 18 months after exposure to such contrast agents.
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.
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.
Defendant Details
| Name (Stock Symbol) | Brief Description |
|---|---|
| Bayer AG | Bayer AG manufactures pharmaceuticals and consumer products. |
| General Electric Company (GE) | General Electric Company operates as a technology, media, and financial services company worldwide. |
| Bracco SpA | Bracco SpA is a pharmaceutical company and a medical device company. |