MRI Drugs

MRI contrast agents are used to increase visibility and improve diagnostic accuracy in MRI scans. Some evidence shows that gadolinium contained in MRI contrast dyes may leave toxic residue in the brain or damage the kidneys. Bayer, GE, Schering, and other gadolinium-based contrast agents (GBCAS) manufacturers have faced multiple lawsuits filed by people who experience neurological side effects, kidney damage, or other serious complications.

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What Are MRIs?

MRI stands for magnetic resonance imaging and is a non-invasive imaging technology that produces detailed 3D images of a person’s anatomy. It can be used to detect disease, help doctors find a diagnosis, and monitor the progress of the patient’s treatment. 

How Do MRIs Work?

The MRI machine is a large, tube-shaped machine that creates a strong magnetic field around the patient that sends pulses of radio waves. The radio waves projected by the MRI scanner move the patient’s atoms away from their original position. When the waves are then cut off, the atoms return to their original position and send back radio signals to the MRI scanner. These signals are received by a computer and converted into an image and that image appears on the monitor for the patient and doctors to view. 

What Are MRI Contrast Agents?

MRI contrast agents are IV medications that increase visibility and allow for more information to be gathered during MRI scans. Contrast agents aren’t permanent dyes but are substances that temporarily change the way the imaging system views the body. This makes it easier for physicians and doctors to notice any abnormalities within the patient. After the MRI, the contrast material is either absorbed by the body or eliminated through urine. 

How Do MRI Contrast Agents Work?

The contrast agent “dyes” or highlights blood vessels, organs, and specific soft tissues so they show up more clearly and help radiologists determine a diagnosis. Without the contrast agents, the tissues that the doctors need to analyze will turn out to be the same color as all the other organs, veins, and blood vessels – different shades of grey. 

MRI scans can be done with or without a contrast agent available.

When Are MRI Contrast Agents Needed?

MRI contrast agents are used when a very detailed image is necessary to find a specific problem within the patient’s body. The contrast agents can prevent the need for additional scans and, instead, can ensure that a successful scan can be done on the first try. Additionally, the agent can highlight even the smallest discrepancies within the body.

MRI contrast agents can be used for any type of imaging scan but are especially useful when identifying tumors in organs like the brain or within someone’s nervous system. The MRI contrast agent can detect tumors, identify if they’re malignant or benign, and determine what stage of growth they’re in.

What Kind of MRI Contrast Agents Are There?

There are multiple types of contrast agents that have their own, specific types of uses as well as pros and cons. Some MRI contrast agents include: 

  • Gastrointestinal
  • Intravenous
  • Intravascular
  • Tumor-specific
  • Hepatobiliary
  • Reticuloendothelial

What Are Gadolinium-Based Contrast Agents?

Gadolinium,-type contrast agents are some of the most popular types of IV dyes as gadolinium concentrates in certain types of tissues to make them more visible during scans. It is also sometimes called “radiopaque” as it appears opaque on radiology imaging scans. 

There are three basic types of gadolinium-based contrast agents (GCBAs) including:

  • Linear standard relaxivity agents (Magnevist, Omniscan, OptiMARK)
  • Macrocyclic agents (Dotarem, Gadavist, ProHance)
  • High-relaxivity agents (Ablavare, Eovist, MultiHance)

What Are Magnevist and Omniscan?

Magnevist and Omniscan are two of the most popular radiopaque agents and have also caused the most concern regarding neurologic side effects and kidney damage. Magnevist and Omniscan are of the older gadolinium type of MRI contrast agents meaning they contain a different type of chemical structure than newer agents. The older agents are linear in chemical structure and may be more likely to release gadolinium molecules, making them more toxic to patients. 

These two agents were FDA approved in 1987 and 1993 respectively and have continued to see widespread use despite the fact that newer agents have been introduced. 

What Are Problems Caused by Magnevist and Omniscan?

The gadolinium agents within Magnevist and Omniscan were unable to enter brain tissue in a healthy person and were limited to circulation in the bloodstream. However, some MRI patients have blood vessels that are considered “leaky” which means that the drug may be able to enter the brain. 

Studies indicate that gadolinium can enter the brain tissue and remain there after the MRI procedure and after the period when the drug is supposed to be expelled from the body. These studies examined the neurologic and brain tissue of deceased patients who had recently used Magnevist or Omniscan. Patients who had multiple MRIs showed higher rates of gadolinium residue. 

What Are the Side Effects of Magnevist and Omniscan?

Less serious side effects of Magnevist and Omniscan can include: 

  • Headache 
  • Dizziness
  • Nausea
  • Hot flashes
  • Burning pain at the injection site
  • Clamminess

More serious effects can include: 

  • Allergic reactions
    • Rash
    • Facial or tongue swelling
    • Difficulty breathing
    • Anaphylaxis
  • Neurological symptoms
    • Confusion
    • Mood swings
    • Speech disorders
    • Seizures
    • Coma
  • Renal symptoms
    • Urinary incontinence 
    • Increased thirst
    • Urinary urgency
    • Swelling
  • Nephrogenic Systemic Fibrosis
    • Raised skin
    • Skin papules
    • Coloring of skin

Any serious adverse event symptoms should be reported to a medical professional immediately and be treated as an emergency. 

What Is Gadolinium Toxicity?

The term “Gadolinium Toxicity” is a term that refers to multiple disorders including acute adverse reactions, NSF, GSC, and GDD. These disorders occur when Gadolinium-based contrast agents are used and gadolinium deposits are observed within the body. The body’s retention of gadolinium can lead to the development of diseases like GDD and NSF.

What Is Gadolinium Deposition Disease (GDD)?

GDD represents symptoms in patients with normal renal function who have received a GBCA agent. As of right now, not much is known about GDD and most assumptions are theories and hypotheses. It is known that GDD is related to GBCA exposure, similar to NSF, but seen in patients with normal renal function. GDD is very uncommon.

What Is Nephrogenic Systemic Fibrosis (NSF)?

NSF is linked with GBCA exposure in patients with renal insufficiency. It is a debilitating and potentially life-threatening disease that is known for its progressive tissue fibrosis. NSF is a rare disease that causes the thickening and hardening of the skin overlying the extremities and the buttocks. 

Are There Safer MRI Contrast Agents Available?

Newer agents have been created, and are still being created, as an alternative to the older MRI agents. Macrocyclic Gadavist agents are available and may be safer than the older, linear agents. These are deemed safer because these agents hold the molecule in a sort of chemical “cage” preventing the gadolinium from seeping into the blood vessels and possibly being deposited into the brain tissue. 

Additionally, in March of 2023, there was a new gadolinium-free contrast agent created called the RVP-001. This product is still being tested in clinical trials, but it’s an alternative to look out for in the future since it claims to be gadolinium-free. 

What Are the FDA’s Warnings About Magnevist and Omniscan?

In December 2007, the FDA required that a black box warning be placed on labeling regarding the risk of NSF in gadolinium-based contrast agents, including Magnevist and Omniscan. 

In September 2010, the FDA released a safety announcement requiring the drug label for gadolinium-based contrast agents to include the warning that the agent may cause NSF and other kidney dysfunction. They also went a step further and recommended that the drugs not be used at all in patients with impaired kidneys. 

Are Magnevist and Omniscan Still on the Market?

Although the FDA has recommended that the drugs be restricted to certain patients, Omniscan and Magnevist are still on the market in the United States as of October 2023. 

The United Kingdom took all gadolinium-based MRI agents off of their markets in February 2018. 

Why Are There MRI Contrast Agents Lawsuits?

Lawsuits claim that the gadolinium in the MRI contrast agents was retained in the body and caused serious, life-altering injuries. Through research, the FDA found a link between GBCAs and conditions such as gadolinium toxicity, gadolinium deposition disease (GDD), and nephrogenic systemic fibrosis (NSF). 

Why Are Plaintiffs Filing MRI Contrast Agents Lawsuits?

Patients have reported a number of serious side effects and adverse reactions associated with the use of MRI contrast agents. The most notable effects that many plaintiffs have recorded include: 

  • Persistent headaches
  • Weight loss
  • Kidney Impairment 
  • Body aches and stiffness
  • Bone and joint pain
  • Brain fog
  • Spongey or rubbery skin
  • Thick, painful ligaments and tendons
  • Burning pain in arms, legs, and torso

What MRI Contrast Agents Lawsuits Are There?

GBCA lawsuits have been filed in both state and federal courts across the country but there are no class-action lawsuits. The most notable GBCA lawsuit is Gena and Chuck Norris’ lawsuit that happened in November 2017. The Norris couple claimed that gadolinium deposits have caused problems with Gena’s health such as muscle weakness, fatigue, periods of intense pain, and a burning sensation.

The Norris couple was seeking $10 million in damages from multiple manufacturers of gadolinium agents including McKesson Corporation, Acist Medical Systems, and Bracco S.P.A. In January 2020, a press release confirmed that the case had been dropped.

Are There MRI Contrast Agents Lawsuit Settlements?

In April of 2010 in Cook County, Illinois, a circuit judge allowed plaintiffs in more than 500 lawsuits to receive compensation for punitive damages. These patients developed NSF after receiving gadolinium and the ruling came quickly after the judge reviewed the evidence provided. There is no recorded amount of how much the victims received in settlements. 

In March 2013 in Ohio, Paul Decker was awarded $5 million for suffering complications after receiving Omniscan. Decker had been diagnosed with renal failure at the time he was given the MRI agent, causing the gadolinium to trigger NSF. They filed the suit with claims that they were not properly warned of the potential risk of using the MRI contrast agent.

Are There Active MRI Contrast Agents Lawsuits?

There are no current class action lawsuits on behalf of those affected by gadolinium in MRI contrast agents.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.