Magnevist



Magnevist

Details

Product: Magnevist
Manufacturer: Bayer Schering Pharma AG

Magnevist is a contrast agent used in magnetic resonance imaging (MRI) to help create clear pictures of the brain, spine, heart, tissue of joints and inside bones.

Patients who are scheduled to receive Magnevist should inform their doctors if they:

  • are pregnant or breast feeding.
  • have any blood disorders, like anemia
  • have a history of renal or hepatic disease, seizure, asthma or allergic respiratory disorders

Common side effects in patients using Magnevist are:

  • dizziness
  • head pain
  • nausea

Infrequent and rare side effects observed in patients using Magnevist are:

  • severely low blood pressure
  • Nephrogenic systemic fibrosis
  • kidney failure
  • allergic reaction
  • restlessness
  • ringing in the ears
  • increased production of saliva
  • dry mouth
  • fever
  • temporary redness of face and neck
  • vomiting
  • stomach cramps
  • weakness

Source: “Magnevist,” Webmd.com, May 2007; “Magnevist,” United States National Library of Medicine, August 2006.


MRI Contrast Agent Lawsuit

Magnetic resonance imaging (MRI) scans are typically taken in order to distinguish pathological, or unhealthy, tissue from normal tissue. MRI scans are generally thought to be harmless to patients because they only expose patients to magnetic fields and radio frequency (RF) radiation. However, there is now a recognized risk to patients who have MRI scans: contrast agents containing gadolinium may place certain patients at risk of a serious disorder. These contrast agents may be the subject of lawsuits against the manufacturers of MRI contrast agents.

Contrast agents are injectable solutions which improve the resolution of interior body images. Contrast agents improve image resolution by increasing the brightness in the parts of the body where the agent is injected. Contrasting agents help to create clear pictures of the brain, spine, heart, tissues of joints and the inside of bones.

Source: Mayo Foundation for Medical Education and Research, “MRI: Viewing your brain and other soft tissues,” November 30, 2006, retrieved November 1, 2007.


MRI Contrast Agent Lawsuit

Magnetic resonance imaging (MRI) scans are typically taken in order to distinguish pathological, or unhealthy, tissue from normal tissue. MRI scans are generally thought to be harmless to patients because they only expose patients to magnetic fields and radio frequency (RF) radiation. However, there is now a recognized risk to patients who have MRI scans: contrast agents containing gadolinium may place certain patients at risk of a serious disorder. These contrast agents may be the subject of lawsuits against the manufacturers of MRI contrast agents.

Contrast agents are injectable solutions which improve the resolution of interior body images. Contrast agents improve image resolution by increasing the brightness in the parts of the body where the agent is injected. Contrasting agents help to create clear pictures of the brain, spine, heart, tissues of joints and the inside of bones.

Source: Mayo Foundation for Medical Education and Research, “MRI: Viewing your brain and other soft tissues,” November 30, 2006, retrieved November 1, 2007.


MRI Contrast Agents and Nephrogenic Systemic Fibrosis (NSF)

Contrasting agents that contain gadolinium, a paramagnetic metal ion, have been linked to a serious skin disorder called nephrogenic systemic fibrosis (NSF). Bayer Schering Pharma AG manufactures Magnevist. Magnevist is used in magnetic resonance imaging (MRI) and during X-Rays for diagnostic purposes.

Gadolinium has been shown to have an adverse effect on patients with kidney disease and renal insufficiency. NSF is a rare disease that was first identified in 1997. NSF can appear in patients with kidney disease within a few days, or as long as 18 months after, undergoing an MRI that involved the use of a contrasting agent such as Magnevist.


About NSF

NSF is a progressive disease that starts with high blood pressure, then hardening and thickening of the skin that develops in the diaphragm, muscles in the thighs, lower abdomen and lungs. Because the side effects resemble allergic reactions and other common disorders, sufferers may not understand they are developing NSF. Side effects can include:

  • dizziness;
  • head pain;
  • nausea;
  • excessively watery eyes;
  • itching;
  • hives;
  • rash;
  • difficulty breathing;
  • chest pain;
  • diarrhea; and
  • anxiety.

NSF can lead to death, and there is currently no known treatment. Improvement in kidney function, either spontaneously or via kidney transplant, has been shown to slow or stop the progression of the disease.


250 Cases of NSF in patients given gadolinium-based contrast agents during MRIs

As of September 2007, the U.S. Food and Drug Administration (FDA) had received reports of more than 250 cases of NSF in patients who were given gadolinium-based contrast agents such as Magnevist. The agents were approved in the 1990s. It is unknown why it has taken so long for the warning and prescribing information to be revised. Did Bayer Schering Pharma AG fail to properly warn patients withkidney diseaseof the risks of using Magnevist? Why is Magnevist still available on the U.S. market?

Sources: “Magenvist,” Webmd.com, May 2007; United States National Library of Medicine, “Magnevist,” August 2006; U.S. Food and Drug Administration, “Important drug warning for gadolinium-based contrast agents,”, September 12, 2007.


FDA: Contrast agents in MRIs black-boxed

On May 23, 2007, the FDA asked manufacturers of all gadolinium-based contrast agents used in MRI to include a black-box warning on the products’ labeling. The warning came after reports of patients developing nephrogenic systemic fibrosis, or NSF.

New black-boxed warnings state that patients with severe renal insufficiency who receive a contrast agent are at risk for developing NSF. It also states that liver transplant patients or patients with chronic liver disease are also at risk if they experience any degree of renal insufficiency.

All reports of NSF made to the FDA involved a patient who had severe kidney failure or impairment. No reports of NSF developing in patients with normal kidney function or with mild to moderate kidney insufficiency have been received. Patients with liver problems also have an increased risk of kidney problems.

MRI Contrast Agents linked to Nephrogenic Systemic Fibrosis (NSF)

The five contrast agents that have been approved for use in the U.S. include:

Single and multiple administrations of contrast agents have resulted in the development of NSF, but reports have not consistently been able to identify a specific agent. When agents could be identified, Omniscan was the most commonly reported agent, followed by Magnevist and OptiMARK.

Doctors are advised to screen patients for kidney problems before administering an imaging agent and should allow enough time to elapse to ensure elimination of a dose before administering another. The recommended dose for contrast agents should not be exceeded.

Source: Food and Drug Administration Release #P07-90, May 23, 2007; Jennifer Corbett Dooren, “MRI contrast agents draw warning,” Wall Street Journal, May 24, 2007.


Hire an Magnevist Lawyer Today – Free Call, No Obligation

If you or someone you love had kidney disease,liver disease, diabetes, or exhibited renal (kidney) insufficiency before the administration of the contrast agent, Magnevist, for MRI or X-ray, or has been diagnosed with Nephrogenic Systemic Fibrosis (NSF), it may be in your best interest to contact a product liability lawyer.

Contact our personal injury law firm today. If you are suffering from nephrogenic systemic fibrosis (NSF), you may be entitled to compensation for the injuries or additional surgical procedures you may suffer as a result. Our legal team is investigating the circumstances of this case. Your information will be reviewed by a lawyer who may be able to help you gain compensation from an Magnevist lawsuit.


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