Gadolinium MRI Contrast Dye Lawsuit Alleges Toxic Effects from MultiHance and OptiMark

Published on July 23, 2018 by Laurie Villanueva

A California man has joined the growing litigation over MRI contrast dyes and the risks allegedly associated with gadolinium retention.

Plaintiff Alleges Severe Health Consequences from Gadolinium Retention

According to a complaint filed in the U.S. District Court, Northern District of California, on June 27th, Jeffrey Steiner claims that his exposure to MultiHance and OptiMark contrast dyes during MRIs resulted in severe adverse health consequences due to the retention of gadolinium in his brain and other organs, including:

  • Fibrosis in his organs, skin, and bones.
  • Severe pain
  • Skin hardening
  • Problems walking
  • Cognitive issues
  • Loss of balance
  • Sensations of burning and tightness in his skin

“Defendants have repeatedly and consistently failed to advise consumers and their healthcare providers of the causal relationship between linear gadolinium-based contrast agents and gadolinium retention resulting in fibrosis in the organs, skin, and bones, retained gadolinium in the brain, and related injuries,” Steiner’s MRI contrast dye lawsuit states. “Defendants knew or should have known of the risks posed by linear gadolinium-based contrast agents to individuals with normal or near-normal kidney function.”

FDA Investigating Gadolinium Retention Risks

Gadolinium is a highly toxic heavy metal that does not occur naturally in the human body. It is used during MRI procedures to improve the images that show up on a scan.

The U.S. Food & Drug Administration (FDA) has approved 8 MRI gadolinium agents for use in the United States:

  • Dotarem (Gadoterate meglumine)
  • Eovist (Gadoxetate disodium)
  • Gadavist (Gadobutrol)
  • Magnevist (Gadopentetate Dimeglumine)
  • MultiHance (Gadobenate Dimeglumine)
  • Omniscan (Gadodiamide)
  • Optimark (Gadoversetamide)
  • ProHance (Gadoteridol)

All of these gadolinium MRI contrast dyes already include a black box warning regarding nephrogenic systemic fibrosis, or NSF, which only occurs in people with pre-existing kidney failure who have been exposed to these agents. However, Steiner is one of a growing number of plaintiffs who have alleged that patients with normal kidney function can experience adverse health consequences due to gadolinium retention from these products.

In December 2017, the FDA announced a new class warning for all gadolinium-based MRI contrast dyes, after a review suggested that gadolinium deposits could be retained in a patient’s body, including the brain weeks, months, or even years after a scan. Among other things, the agency warned that linear agents, including MultiHance and Optimark, resulted in more retention and retention for a longer time compared to gadolinium products called macrocyclic agents.

Other linear gadolinium agents include Eovist, Magnevist, and Omniscan.

“Health care professionals should consider the retention characteristics of each agent when choosing a GBCA for patients who may be at higher risk for gadolinium retention, including those requiring multiple lifetime doses, pregnant women, children, and patients with inflammatory conditions,” the FDA cautioned.

As part of its ongoing investigation of gadolinium-based MRI contrast dyes, the FDA has ordered the manufacturers of these products to conduct new studies to better evaluate their possible health risks.

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