FDA Releases New Gadolinium Label
Last month, the FDA released a new product labeling for all gadolinium-based contrast agents (GBCAs) were posted on the FDA’s website. This is the second label adjustment in less than six months. In December 2017, the FDA required GBCA manufacturers to revise product labeling and create a Medication Guide for each GBCA. The purpose of the Medication Guide is to provide patients with information about gadolinium retention in the body so that they can make an informed decision before agreeing to have an MRI with contrast.
Gadolinium is a chemical element carrying the atomic number 64 and the atomic symbol Gd. Belonging to a group of elements in the periodic table called Lanthanides, the chemical is a rare earth element typically used in microwave applications, color TV tubes, synthetic gemstones, compact discs, and computer memory. This chemical element is widely used as an injectable contrast agent when patients undergo magnetic resonance Imaging (MRI) and magnetic resonance angiography (MRA) scans. Research has found that this chemical element is a toxic metal and any amount that remains in the brain and other parts of the body has the potential to have a harmful effect. The long-term effects of gadolinium deposition are still unknown as research is ongoing.
New Gadolinium Label
In April 2018, the FDA required GBCA manufacturers to revise product labeling and create a Medication Guide for each GBCA. The Medication Guide for each agent will mention that “many doses of gadolinium medicines” are a possible risk factor. Medical professionals intravenously administer Gadolinium-based contrast agents. However, these can also have a toxic effect even after a single dose. Dr. Richard Semelka first coined this toxic effect as Gadolinium Deposition Disease.
Dangers of Gadolinium Deposition Disease
Gadolinium Deposition Disease (GDD) is when those with normal or near normal renal function develop persistent symptoms that arise within two months after the administration of GBCAs. Dr. Richard Semelka and his co-authors proposed the name in his paper Gadolinium in Humans: A Family of Disorders. Symptoms of the disease are similar to the previously noted side effect of nephrogenic systemic fibrosis (NSF).
- A persistent headache
- Bone and joint pain
- “Brain Fog”
- Thickening of soft tissue
- Skin that appears spongy or rubbery
- Painful tendons and ligaments
- Tightness in hands and feet
- Burning, cutting or pins and needles pain in arms, legs, and torso
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 by 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 consultation. We have over 20 years experience helping consumers injured by unsafe products manufactured by large companies.