Despite growing concern and evidence that gadolinium-based contrast agents (GBCAs) pose serious health risks, the FDA has yet to recall the products or suspend use. However, federal health regulators do urge health care providers to consider the retention characteristics of GBCA’s, particularly for pregnant women, children, patients with inflammatory diseases and those requiring ongoing doses for the remainder of their lives.
Showard Law Firm continues to monitor FDA regulatory actions regarding Gadolinium toxicity and side effects and provides outstanding legal advocacy to those who have suffered injury through no fault of their own. If you are experiencing MRI dye complications, or want more information about filing a Gadolinium lawsuit, please contact our Arizona law office for a complimentary case review. The consultation is confidential and without obligation.
FDA Actions & Warnings Regarding GBCA’s
The following is a timeline of regulatory actions and safety communications issued by FDA in regards to Gadolinium-containing contrast agents for Magnetic Resonance Imaging.
2006 – FDA Announces Link Between GBCA’s and Nephrogenic Systemic Fibrosis
On June 8, 2006, the FDA published a public health advisory regarding a possible connection between exposure to gadolinium-based contrast agents and a disease known as Nephrogenic Systemic Fibrosis (or Nephrogenic Fibrosing Dermopathy). According to the announcement, the agency learned of 25 cases of Nephrogenic Systemic Fibrosis in patients with renal failure who were treated with Omniscan during a Magnetic Resonance Angiography (MRA) test. The patients developed symptoms of NSF, which causes skin and organ tissue to become rigid, within three months of exposure to GBCA’s. These are marketed in the United States under the trade names OptiMARK, ProHance, Magnevist, Omniscan and MultiHance.
2007 – FDA Mandates Black Box Warning for NSF risks
One year later, the FDA mandates a Black Box Warning on the packages of all Gadolinium-containing contrast agents. The Black Box warning reads:
“Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with: acute or chronic severe renal insufficiency, or acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period… avoid use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MR). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs.”
2009 – Safety Announcement regarding GBCA product label revisions
The FDA issued a safety announcement on September 9, 2010 stating it was requiring changes in the product labels for GBCAs to diminish risk of nephrogenic systemic fibrosis (NSF), a rare but debilitating condition observed in certain patients with kidney dysfunction. The amended labeling cautions medical professionals to screen patients for acute kidney injury or severe kidney disease before administering gadolinium agents.
2015- Safety Communication about Gadolinium Brain Deposit Risk
July 27, 2015 saw the first FDA drug safety communication regarding possible gadolinium accumulation in the brain with repeated MRIs. The agency stated it would be investigating, in conjunction with its National Center for Toxicological Research, the risks of gadolinium retention. The advisory cited recent medical literature where deposits of GBCAs were found in the brains of some patients who had undergone multiple MRI scans long after the test.
2017- Drug Safety Communication on Gadolinium Retention
On May 22, 2017, the FDA issued a follow-up communication stating regulators had not found adverse health effects from gadolinium deposits in the brain following MRI scans that used gadolinium-based contrast agents. The advisory said there was no evidence (to date) that gadolinium accumulation in the brain from any of the available GBCAs, is harmful.
The agency reviewed scientific publications involving human and animal studies that showed evidence of gadolinium retention in the skin, bone and brain. The studies indicated that linear GBCAs retain more gadolinium in the brain than macrocyclic agents.
2017- FDA issues a New Class Warning for GBCAs
The FDA issued new safety measures and an updated class warning for all gadolinium-based contrast agents for MRI imaging. The new warning concerns gadolinium remaining in the brain and bodily tissues for months after receiving the drugs. The communication states that “Gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function, and we have concluded that the benefit of all approved GBCAs continues to outweigh any potential risks.” The GBCA agents approved by the FDA include: Dotarem, Eovist, Magnavist, Gadavist, Omniscan, OptiMark, ProHance and MultiHance.
2018 – Revised Drug Labels for Gadolinium-Based Contrast Agents
Revised drug labels for all GBCA’s are now enforced by the FDA. The labels include warnings about Gadolinium Retention that reads:
“Gadolinium is retained for months or years in several organs. The highest concentrations (nanomoles per gram of tissue) have been identified in the bone, followed by other organs (e.g. brain, skin, kidney, liver, and spleen. The duration of retention also varies by tissue and is longest in bone… Consequences of gadolinium retention in the brain have not been established. Pathologic and clinical consequences of retention in skin and other organs have been established in patients with impaired renal function [see Warnings and Precautions (5.1)]. There are rare reports of pathologic skin changes in patients with normal renal function. Adverse events involving multiple organ systems have been reported in patients with normal renal function without an established causal link to gadolinium retention.”
Explore your legal options
Litigation is already emerging regarding Gadolinium toxicity and Gadolinium Deposition Disease (GDD). Learn more about your rights to legal compensation by consulting with Showard Law Firm.
Additional Resources on Gadolinium FDA Warnings:
- Gadolinium Toxicity, Tag Archives FDA https://gadoliniumtoxicity.com/tag/fda/
- FDA, Information on Gadolinium-Based Contrast Agents https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm
- FDA, FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings https://www.fda.gov/Drugs/DrugSafety/ucm589213.htm
- Medscape, FDA to Require Warning Labels on Gadolinium-Based Contrast Agents https://www.medscape.com/viewarticle/890359