FDA Issues New Warnings for Gadolinium
MRI contrast agent under investigation; linked to life-threatening disease.
Researchers have discovered that gadolinium, a heavy metal that aids contrast imaging in MRIs, may linger in the body for months – even years – following the procedure in which it was administered. The effects of this build-up, known as gadolinium retention, have been linked to a serious health condition called nephrogenic systemic fibrosis (NSF) in people with pre-existing kidney failure. Other adverse effects of gadolinium are currently being investigated.
“We are requiring a class-wide warning about gadolinium retention in the labeling of GBCAs (Gadolinium-Based Contrast Agents) and a new medication guide that should be presented to patients in advance of receiving a GBCA,” – Janet Woodcock, M.D., director of FDA Center for Drug Evaluation and Research
The FDA has also ordered GBCA manufacturers to conduct further research into the safety of their contrast agents.
What is gadolinium?
Gadolinium is a heavy metal used in Gadolinium-Based Contrast Agents (GBCAs). GBCAs, which are typically intravenously injected, highlight internal organs, tissues and blood vessels during MRIs. Although the kidneys work to eliminate GBCAs from the body, trace amounts of gadolinium may remain.
What are the potential risks of gadolinium?
- In people with pre-existing kidney failure, gadolinium retention may trigger nephrogenic systemic fibrosis (NSF), a chronic and sometimes fatal disease that can affect the skin, internal organs, and cause debilitating shortening of muscles and tendons in the joints.
- Populations vulnerable to gadolinium retention may include: patients who require multiple doses of GBCAs over long periods of time; people with inflammatory conditions; pregnant women; children.
- The FDA continues to gather data on the potential risks of GBCAs.
Manufacturers Issue Warning Letter to Physicians and Facilities
The Manufacturers and distributers of Gadolinium products issued a warning letter to physicians and healthcare facilities. Click here to read the letter.
Have you suffered adverse effects from gadolinium?
Our attorneys are investigating patient claims related to adverse reactions from gadolinium. If you or a loved one have experienced complications or negative effects from gadolinium, contact the gadolinium attorneys at Aylstock, Witkin, Kreis & Overholtz today for a free consultation. There is never a fee unless we recover for you.
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