The U.S. Food and Drug Administration announced in December 2017 a new warning label for all Gadolinium-based agents and that it would require manufacturers of Gadolinium-based contrast agents (GBCAs) to conduct human and animal studies to examine risks to the kidneys and other potential effects.
Motley Rice is reviewing claims of harm involving GBCAs, including those manufactured by Bayer HealthCare Pharmaceuticals Inc., Bracco Diagnostics Inc., GE Healthcare, Guerbet LLC, and Guerbet subsidiary Liebel-Flarsheim Companny LLC.
Contact an attorney
If you or a loved one had several MRIs with the contrast dye Gadalinium and suffered serious side effects, you may have a claim. Contact medical attorney Carmen Scott by email or call 1.800.768.4026 for more information or to discuss your potential claim.
Gadolinium side effects
While the effects of Gadolinium retention continue to be studied, potential serious side effects to the brain, bone, skin, kidney, liver, or spleen are being investigated.
The FDA also reports that the metal contrast agent can cause nephrogenic systemic fibrosis (NSF) in patients with pre-existing kidney failure. Symptoms of NSF may include:
Swelling, tightening or hardening of the skin
Burning, itching or severe sharp pain
Blisters or ulcers
Limitation of joint motion
Reduced internal organ function
Yellow plaques on the white surfaces of the eyes
In some patients, severe disability or death may result from NSF.
The FDA has also received reports of adverse effects to multiple organ systems in patients with normal kidney function. Patients at higher risk include those requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions.
Gadolinium retention background
In December 2017, the FDA announced that it would require a new class warning and additional safety measures addressing Gadolinium retention. In May 2018, manufacturers Bayer, Bracco, GE and Guerbet issued a warning to healthcare providers notifying them of updated Warnings and Precautions on product labels. Labels now warn that Gadolinium can be retained for months or years in several organ systems throughout the body. The warnings go on to state that “consequences of gadolinium retention in the brain have not been established.” The notifications also instruct physicians to provide patients with medication guides detailing the risks of Gadolinium retention prior to receiving a GBCA.