Gadolinium Deposition Disease Recalls and Studies

Gadolinium, the contrast dye that is used in MRIs and MRAs has come under fire from the FDA. In 2007, the agency issued a black box warning. This is the most severe warning a medication or drug can have.  Then, additional concerns sparked a FDA review of all gadolinium products. However, researchers have been citing dangers with this chemical agent as early as 1984.

Studies Noting Dangers

There have been peer-reviewed studies outlining the dangers of this chemical since 1984. 

  • 1989: Reports emerged that intracerebral masses “remained enhanced on MRI images obtained 8 days after injection of gadolinium DTPA dimeglumine (Magnevist).” Subsequent chemical analysis revealed that a high concentration of gadolinium remaining in the tissue. 
  • 1996: Study with rats found gadolinium has neurotoxic and neuropathological potential. 
  • 2000: Study suggests DNA cleavage by rare earth elements, including gadolinium, in humans.
  • 2002: Gadolinium retention found in canines.
  • 2004: Gadolinium broke free from its bonds in people with normal renal function. This was attributed to the competition by other essential metals in the body such as zinc, copper, and iron. 
  • 2007: Three months after the FDA approval of Omniscan, the preclinical safety assessment and pharmacokinetic data were published describing its pharmacokinetics in rats, rabbits, and cynomolgus monkeys. These studies demonstrated that quantifiable concentrations of gadolinium were persistent in both the renal cortex and areas around bone cartilage.
  • 2007: Dr. Weinmann, the director of contrast media research at Bayer in Germany admitted that he and fellow researchers have known about a potential problem since the 1980’s. Animal studies showed gadolinium retention any symptoms in mice. These results were reported but never published.
  • 2011: Gadolinium causes neural cell death.
  • 2014: First reports of gadolinium deposition and retention
  • 2016: Gadolinium deposits found in bone and brains of people with normal renal function
  • 2016: N.I.H recommended institutional review of policies for gadolinium administration
  • 2016: Dr. Semelka published the key study naming Gadolinium Deposition Disease

Recalls in Other Countries

There have been a number of meetings and recalls in other countries. In March 2017,  The European Medicines Agency (EMA) recommended linear agents be removed from the market including, MultiHance, Optimark, Omniscan, and Magnevist. Then, in July 20, 2017, the EMA suspended the use of GBCAs.

In 2017, Japan and Singapore restricted their use, and the UK suspended production the following month. 

FDA Action

In 2005, the FDA announced an investigation into the risk of brain deposits before issuing a black box warning in 2007.  Ten years later, Medical Imaging Drug Advisory Committee (MIDAC) recommended adding a warning identifying that gadolinium may be retained following use in MRIs, and the risk is higher with linear GBCAs. A month later, the FDA issued a warning gadolinium retention from MRI contrast agents, specifically regarding the increased risk of linear GBCAs. 

Free Case Evaluation

A gadolinium lawsuit may be an option for patients suffering from gadolinium retention and related complications. Gadolinium, used in dyes to increase the clarity of MRI and MRA scans, can create chemical element retention in the body, Therefore, this increases the risk of gadolinium deposition disease and nephrogenic systemic fibrosis. These conditions are accompanied with symptoms that include severe physical pain and cognitive difficulties. Affected patients and their loved ones may be able to file a lawsuit and recover damages.

For more information, contact The Michael Brady Lynch Firm. We offer free, confidential, no obligation consultations. We have over 20 years experience helping consumers injured by unsafe products manufactured by large companies.

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