Gadolinium Side Effects
Gadolinium is a metal found in contrast agents (dyes) used in magnetic resonance imaging (MRI) scans, including a form of MRI called magnetic resonance angiography (MRA). MRAs help doctors see blood vessels up close; however, when enhanced with gadolinium they can place some patients particularly patients with kidney disorders at risk of developing serious gadolinium side effects. Some patients with kidney disease have had gadolinium reactions leading to a potentially fatal condition called nephrogenic systemic fibrosis (NSF), also known as nephrogenic fibrosing dermopathy (NFD), which can lead to gadolinium renal failure.
Due to the severity of this condition, in May of 2007 the FDA issued a Public Advisory Warning notifying patients with kidney problems of the potential gadolinium side effects. In addition, the FDA made the manufacturers of gadolinium contrast dyes add a "black box warning" to the packaging of their products. Nonetheless, gadolinium contrast agents are still on the market awaiting further study. If you or someone you know has been harmed or suffered from gadolinium kidney failure due to NSF gadolinium related complications, a personal injury lawyer can help you determine whether you have a legal right to compensation.
Signs & Symptoms of Gadolinium Toxicity
The signs and symptoms of a reaction to gadolinium (gadolinium toxicity) can range from mild headaches to potentially life-threatening gadolinium side effects. The most common side effect of gadolinium exposure is an allergic reaction, characterized by rashes, sweating, itching, hives and/or facial swelling.
Below are just some of the signs and symptoms that may indicate that you have experienced a side effect of gadolinium toxicity. The most serious gadolinium side effect is nephrogenic systemic fibrosis/nephrogenic fibrosing dermopathy (NSF/NFD), a scarring condition that can lead to total gadolinium kidney failure.
Signs & Symptoms of Gadolinium Toxicity
|Allergy-specific||Kidney Patients (NSF/NSD)||Other more common||Other less common|
|Rashes||Skin swelling / tightening / thickening||Mild headache||Low blood pressure|
|Itching||Joint problems||Localized pain||Blood clots|
|Hives||Muscle weakness||Blood vessel irritation|
|Facial Swelling||Deep bone pain|
|Shortness of breath||Rapid-onset hypertension|
Sources: Food and Drug Administration (FDA); University of California, San Francisco; The International Center for Nephrogenic Fibrosing Dermopathy Research (Yale University)
NSF/NSD is a systemic disorder caused by exposure to a gadolinium-based contrast agent during an MRA scan. It was first discovered in 1997, when the Danish Medicines Agency reported 25 cases of the condition in patients with kidney problems. To date, only patients with kidney related ailments have reported NSF gadolinium related symptoms.
NSF/NSD may be associated with a number of conditions and events, including:
- Coagulation issues
- Recent surgery (especially vascular surgery)
- Failed kidney transplant
- Sudden onset of kidney disease
NSF/NSD is characterized by fibrosis, or scarring, in the skin and connective tissues. It can affect the diaphragm, lungs, lower abdomen, inner lung vessels, thigh muscles and other areas.
There is currently no effective treatment for NSF/NSD. However, improvement in kidney function has been known to slow or gradually reverse the effects of the condition. Experimental treatments are currently being studied at research institutions such as Yale University and Loma Linda University.
Manufacturers and distributors of drugs and medical products have a duty to warn doctors and patients of any potential dangers associated with their products. Companies that fail to do so may be liable for any harm that is caused by their defective drugs or products.
Many of the patients affected by NSF/NSD have filed gadolinium lawsuits or joined class action gadolinium lawsuits claiming that the manufacturers of gadolinium-based contrast agents were negligent or violated product liability and/or pharmaceutical liability statutes. Some of these lawsuits, including those pursuing negligent cause of death claims, also allege that the manufacturers of gadolinium contrast dyes failed to perform proper tests on their products.
There are five brands of gadolinium contrast agents on the market:
- Omniscan (gadodiamide), by GE Healthcare
- ProHance (gadoteridol), by Bracco
- OptiMARK (gadoversetamide), by Mallinckrodt
- Magnevist (gadopentetate dimeglumine), by Bayer Healthcare
- MultiHance (gadobenate dimeglumine), by Bracco
If you or someone you know has been harmed by a gadolinium contrast agent, a personal injury attorney can help explain your rights and determine whether you are eligible for compensation.
A company whose product is found to be defective may be held liable for damages, regardless of whether the company acted negligently in the manufacture or distribution of its product.