What is Gadolinium?
Gadolinium is a silvery-white, rare-earth metal that is frequently used in magnetic resonance imaging (MRI) procedures. Dyes that contain gadolinium, known as gadolinium-based contrast agents or GBCAs, are injected into patients in order to produce sharper, more vivid MRI scans, making it easier to detect and diagnose serious health problems, such as tumors or other signs of cancer.
Every year millions of patients in the United States undergo MRI scans that involve the use of gadolinium contrast agents, as part of their treatment for conditions ranging from spinal injuries to inflammatory diseases. Although gadolinium is toxic to humans, the manufacturers of GBCAs insist that their products are safe because the metal is mixed with other chemicals that help to protect the patient until the compound is expelled from the body through urination.
But in some cases, gadolinium may be retained in the patient’s body for months or years after the procedure. On December 19, 2017, the U.S. Food and Drug Administration issued a new Drug Safety Communication for all GBCAs, calling for more research into the safety of the contrast agents and more disclosure to patients of the potential risks involved. The alert identified certain patients who are at greater risk of gadolinium retention, including “those requiring multiple lifetime doses, pregnant women, children, and patients with inflammatory conditions.”
What are the Health Risks?
A small percentage of patients have reported minor side effects from GBCA injections, including headaches, nausea, or irritation at the injection site. In recent years, more serious concerns have been raised about the possible long-term effects of gadolinium retention, prompting numerous lawsuits.
Plaintiffs in these lawsuits have claimed various injuries from gadolinium toxicity, including:
- Cognitive impairment
- Chronic pain
- Kidney damage
- Respiratory issues
In addition, some patients allege that exposure to gadolinium has led to nephrogenic systemic fibrosis, a rare and potentially fatal condition characterized by a hardening of the skin and organs and bone pain.
Alternatives To GBCAs
While the debate rages over the long-term effects of gadolinium toxicity, a growing number of researchers are urging alternative therapies that don’t involve the use of a heavy metal in MRI scans. In 2017 the European Medicines Agency recommended restricting the use of certain GBCAs that have been more closely linked to long-term complications.
The Dangerous Drug and Medical Device Lawyers at FDAzar
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