Nephrogenic Systemic Fibrosis (NSF) Nephrogenic Fibrosing Dermopathy (NFD)
 Gadolinium |
Gadolinium Side Effects |
NSF / NFD |
Gadolinium Lawsuits |
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The U.S. Food and Drug Administration (FDA) has recognized the potentially fatal link between gadolinium exposure and the onset of nephrogenic systemic fibrosis / nephrogenic fibrosing dermopathy (NSF/NFD). Contrast agents with gadolinium are used during magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) procedures to help doctors better distinguish between abnormal and normal tissue growths.
The first side effects of gadolinium were discovered in 1997; since then, more than 1,000 cases have been diagnosed worldwide. A recent Yale report stated that 95 percent of people suffering from NSF/NSD had undergone an MRI involving a gadolinium-based contrast agent. All known cases of the disease involve patients suffering from severe kidney dysfunction.
NSF/NSD causes fibrosis of the skin and connective tissues throughout the body. Patients may experience skin hardening, which leads to decreased mobility of the joints. NSF/NSD can also affect the diaphragm, thigh muscles, lower abdomen and lung vessels. The disease may lead to severely restricted movement, breathing troubles and, in some cases, death. There is currently no consistently effective treatment for NSF/NSD.
The symptoms of these gadolinium side effects can appear relatively quickly following a single procedure or can take over a year to present. Common symptoms of NSF/NSD include:
- Burning, swelling, itching and hardening of the skin.
- Reddened or darkened patches on the skin.
- Raised yellow spots on the whites of the eyes.
- Inability to properly straighten the arms, hands and legs.
- Muscle weakness.
- Deep hip bone or rib pain.
Types of Gadolinium-Based Contrast Agents
The FDA originally approved the first gadolinium-based contrast agent in 1988; today, five such drugs are on the market. Although Omniscan is used most often, the FDA has yet to determine if one gadolinium-based contrast agent poses a greater risk of NSF/NSD than the others. The five available agents are:
- OptiMARK (gadoversetamide), manufactured by Mallinckrodt.
- ProHance (gadoteridol), manufactured by Bracco.
- Magnevist (gadopentetate dimeglumine), manufactured by Bayer Healthcare.
- MultiHance (gadobenate dimeglumine), manufactured by Bracco.
- Omniscan (gadodiamide), manufactured by GE Healthcare.
The strong, documented connection between gadolinium exposure and NSF/NSD has led the FDA to require that black box warnings (the government’s strongest warning) be placed on all drug packaging and literature to better alert doctors and patients.
Legal Recourse
The gadolinium lawyers at Levin, Simes, Kaiser & Gornick have years of experience protecting their clients’ rights. Due to the link that has been established between gadolinium-based contrast agents and NSF/NSD, a drug company that manufactures these agents could face a gadolinium lawsuit since it may be liable for any injury or death associated with its drugs. In the past, courts have determined that drug companies that manufacture potentially lethal drugs without sufficiently warning doctors and patients about the possible side effects are guilty of negligence.
If you or someone you know has experienced symptoms associated with NSF/NSD following an MRI or MRA involving a gadolinium-based contrast agent, contact Levin, Simes, Kaiser & Gornick at (800) 901-4001. These gadolinium lawyers have years of experience helping people understand their legal rights.
Levin Simes Kaiser & Gornick, LLP
44 Montgomery Street, 36th floor
San Francisco, CA 94104
Ph: 1.800.901.4001
Fax: 415.981.1270
