Medical Devices:
NSF Linked to Gadolinium
Gadolinium Injection Risk Details
- This Alert Affects: Patients diagnosed with nephrogenic systemic fibrosis who have undergone a MRI or MRA with a gadolinium-containing contrast agent.
- Damages: Gadolinium has been linked to nephrogenic systemic fibrosis (NSF), also known as nephrogenic fibrosing dermopathy, in kidney patients. NSF causes hardening and thickening of the skin and organs.
- Company(ies): Bayer Schering Pharma, GE Healthcare, Mallinckrodt, Inc. and Bracco Diagnostics, Inc.
- Additional Details: Gadolinium contrast dyes are injected into a patient prior to a MRI or MRA. The dye enhances the image, giving the doctor the opportunity to spot abnormalities.
- Date: The FDA released their first of three Gadolinium warnings in June 2006. After another warning in Dec. 2006, Gadolinium-containing contrast agents then received a Black Box Warning in May 2007 to highlight the risk of NSF in kidney patients.
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Gadolinium Injection Risk Lawsuits
Gadolinium is found in MRI and MRA contrast agents, which are injected into a patient prior to the scan. These contrast dyes are used to enhance the image, making it easier for doctors to spot abnormalities. However, gadolinium's use is now being questioned, as in 2007 the Food and Drug Administration (FDA) issued its strongest warning (the "Black Box Warning") for MRI/MRA contrast agents that contain Gadolinium, because it has been linked to a potentially fatal disease in patients with existing kidney conditions. MRI or MRA patients with severe kidney (renal) problems who are injected with a Gadolinium containing contrast agent are at risk of contracting a potentially life-threatening disease known as Nephrogenic Systemic Fibrosis (NSF), also called Nephrogenic Fibrosing Dermopathy (NFD). There is no consistently effective treatment.
After an MRI or MRA, healthy patients can flush the gadolinium out of their systems. However, patients with kidney problems cannot do this so easily, leaving gadolinium in the body for an extended period of time. These patients have developed nephrogenic systemic fibrosis (NSF), also known as nephrogenic fibrosing dermopathy (NFD). NSF causes thickening and hardening of the skin, and can severely limit movement. Some patients with NSF are unable to walk. People experiencing NSF may have the following symptoms:
- Skin swelling, hardening or tightening
- Yellow raised spots on the eyes
- Joint stiffness
- Deep bone pain in the hips or ribs
- Muscle weakness
- Harm to connective tissues of the body
- Broken bones
- Hardening of internal organs
- Muscle weakness
- Reddened/darkened skin patches, papules, or plaque
- Burning, itching, or severe sharp pains in the affected areas
- Inability to walk or extend joints in extreme cases
Gadolinium has been approved by the FDA as a contrast agent for MRI's, and is marketed under the following brand names in the United States:
- Magnevist (gadopentetate dimeglumine) manufactured by Bayer Schering Pharma
- Ominiscan (gadodiamide) manufactured by GE Healthcare
- OptiMARK (gadoversetamide) manufactured by Mallinckrodt, Inc.
- MultiHance (gadobenate dimeglumine) manufactured by Bracco Diagnostics, Inc.
- Prohance (gadoteridol) manufactured by Bracco Diagnostics, Inc.
These dyes are not FDA-approved for use in MRAs, though doctors sometimes use them regardless of the fact MRAs require three times the dose of MRIs.
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