Gadolinium or a Gadolinium-Based Contrast Agent (GBCA) is a contrast dye commonly used in MRIs and MRAs to enhance the quality of imaging. It was originally believed that the dye would be filtered through the kidneys and eliminated from the body within 24 hours as promised by the manufacturers. Studies have shown that this is not the case and that gadolinium can be retained in the body for years. The effects of gadolinium retention in the body can be both painful and debilitating.
It is now recognized that not only does gadolinium cause Nephrogenic Systemic Fibrosis (NSF) in patients with impaired renal function, but it also causes conditions in patients with normal kidney function as well. These conditions include:
- Gadolinium Storage Condition- (GSC) is a condition wherein a person has a normal kidney function, but is diagnosed with excess gadolinium in the body. The patient may not be exhibiting any symptoms, but still has accumulation of gadolinium in their brain and tissue.
- Gadolinium Deposition Disease-(GDD) involves situations where a patient has normal kidney function but develops persistent or painful symptoms within a few hours or several weeks after being injected with a gadolinium contrast agent. The symptoms are often painful and debilitating and they may present for several weeks, months or years.
Side Effects Include:
- Persistent headache;
- Bone and joint pain;
- Brain fog;
- Subcutaneous soft tissue thickening;
- Pain in tendons and ligaments with a thickened appearance;
- Tightness in hands and feet;
- Burning, cutting, or pins and needles sensations in the arms, legs, and torso.
Linear GBCAs have proven to be the most dangerous and we are investigating and pursuing cases against many gadolinium manufactuers including Bayer, GE, Bracco and Guerbet. In the last few years the FDA has been investigating the dangerous side effects of GBCAs and have reported many side effects of gadolinium including: pain and burning within hours or days of receiving the agent; cognitive difficulties, headaches and memory impairment; central nervous system problems; and skin and musculoskeletal complaints.
Various countries have pulled or suspended linear gadolinium agents:
- November 2016- A Gadolinium Retention Evaluation Consortium was created and held its first meeting in Naples, Italy.
- March 2017-The European Medicines Agency (EMA) recommended that linear agents be removed from the market, including Optimark, Magnivest, Omniscan and MultiHance.
- July 20, 2017-The EMA suspended the above GBCAs.
- November 28, 2017- Japan restricted the use of several GBCAs.
- December 14, 2017- The United Kingdom issued a drug safety update regarding the use of GBCAs.
- January 2018- The UK suspended the production of linear GBCAs.
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March 5, 2018- Singapore recommends restricted use of GBCAs.
In the United States, the FDA has taken various actions to warn the public about the dangers of GBCAs including:
- 7/27/2015: Safety Announcement- The FDA announced that it was investigating the risk of brain deposits following mulitiple use of GBCAs.
- 5/22/2017: Drug Safety Communication- The FDA acknowledged that GBCAs may be associated with gadolinium retention in the brain or other body tissues.
- 9/8/2017: Medical Imaging Drug Advisory Committee recommended a warning be added that gadolinium, particularly linear gadolinium, may be retained following an MRI.
- 12/19/2017: The FDA issued a warning regarding gadolinium retention from MRI contrast agent. The FDA demands a label change and additional studies to be conducted.
- 5/16/2018: In addition to approving the updated prescribing information concerning the gadolinium retention safety issues, the FDA also approved new patient Medication Guides for all GBCAs.
NATIONWIDE GADOLINIUM LAWSUIT ATTORNEYS
If you or a loved one have suffered from the effects of Gadolinium, you may be entitled to compensation. Contact the attorneys at Ennis & Ennis, P.A. today for a free nationwide case evaluation. No fees or expenses unless you receive financial compensation.
