Gadolinium

  • gadolinium

Gadolinium is a chemical element which is silvery white in color and was discovered in 1880. It has some paramagnetic properties because of which it is used intravenously in diagnostic imaging procedures to better the quality of magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA).

Magnetic Resonance Imaging (MRI) is a medical imaging procedure used for making images of the internal structures of the body. MRI scanners work by making images using strong magnetic fields and radio waves (radiofrequency energy). Gadolinium-Based Contrast Agents (GBCA) are intravenous drugs used in diagnostic imaging procedures to enhance the quality of magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA).

FDA has mostly approved all the Gadolinium-based contrast agents (GBCAs) for an intravenous (IV) administration in radiology imaging as they can provide greater contrast between normal and abnormal tissues within the body. Gradually, it was noticed that these contrast agents do not leave the body immediately as they were supposed to. Gadolinium is excreted out of the body through kidneys, but due to its deposition in the body, it was found to cause Gadolinium Deposited Disease (GDD) giving permanent injuries to Kidneys.

Serious Alleged Injuries may include:

  • Gadolinium Deposition Disease Symptoms
  • Nephrogenic Systemic Fibrosis (NSF)
  • Bone pain
  • Joint pain
  • Skin and subcutaneous tissue burning pain
  • Chemo brain or brain fog
  • Skin changes
  • Thickening / discoloration of the skin
  • “Pins and needles” in the arms and legs
  • Headache

FDA Safety Warnings:

FDA in 2007 issued Black Box Warning and urged to avoid the use of Gadolinium in MRIs and MRAs but only for patients suspected or known to have impaired drug elimination.

On December 23, 2010, FDA issued a Safety Warning Communication for use of Gadolinium-based contrast agents in patients with kidney dysfunction.

On July 7, 2015, and later a follow-up on May 22, 2017, FDA issued a Safety Warning about Gadolinium deposits in the brain following repeated usage of Gadolinium-based contrast agents for MRI and confirmed no harmful effects on the brain.

On December 12, 2017, FDA issued a statement that Gadolinium requires a new class warning.

Lawsuit Allegations:

Gradually lawsuits are piling up knowing they were not adequately warned about these side effects in both federal and civil courts.

Evidences:

  • Indication of Usage in Radiology Records
  • Duration and Frequency of Gadolinium usages
  • Complications and their treatment after exposure

Medical Record Review and claim validation of Gadolinium case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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