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Amid continuing concerns about the serious and potentially life-threatening side effects of MRI contrast dyes, federal regulators are requiring new warning labels about the risk of gadolinium retention in the body.
The FDA issued a drug safety communication on December 19, announcing new safety measures that will be required for gadolinium-based contrast agents (GBCA’s). However, the agency notes that it has not linked gadolinium retention directly to any adverse health effects in patients with normal kidney functions.
In recent months, a number of MRI toxicity lawsuits have been filed against the manufacturers of gadolinium contrast agents, such as Magnevist, Gadavist and Omniscan.
The complaints allege that use of MRI dyes to enhance imaging tests have left users with a condition known as gadolinium deposition disease (GDD), which involves various symptoms, including reduced cognitive function, headaches, bone and joint pain, tendon and ligament pain, thickening of soft tissues and other problems. The condition is considered incurable and progressive, meaning that it worsens over time, raising concerns about the safety of gadolinium contrast agents.
The FDA’s new label requirements call for a new Medication Guide detailing gadolinium retention and possible side effects, which all patients receiving the contrast agents will be asked to read. The agency will also require all gadolinium-based contrast agent manufacturers to conduct new human and animal studies to determine their safety. However, the FDA indicates that it currently considers the benefits of gadolinium contrast agents to outweigh potential risks.
The FDA is also recommending that health care professionals consider the fact that the body retains gadolinium when deciding whether to give it to patients that may be at higher risk of health problems. These include women who are pregnant or think they may be pregnant, patients with kidney problems, children, and patients when inflammatory conditions. The recommendations also suggest that repeated use of the contrast agents be minimized where possible, particularly when MRIs are scheduled closely together.
Patients are urged to tell their health care professionals whether they are pregnant or may be pregnant, whether they have kidney problems, and the date of their last MRI with gadolinium, or whether they have had repeated MRI scans that involved the use of gadolinium contrast agents.
Known Gadolinium Health Risks
In prior years, concerns emerged about the safety of MRI gadolinium contrast agents, after it was linked to a rare and life-threatening condition known as nephrogenic systemic fibrosis (NSF), which was found to occur among patients with impaired kidney function, causing their skin to thicken and harden, severely restricting movement.
Sometimes referred to as gadolinium associated systemic fibrosis, NSF is a painful disorder that has no known cure and often results in confinement to a wheelchair and then death.
In 2007, the FDA limited gadolinium contrast doses in most patients and contraindicated it for others, which limited the risk of NSF. In September 2010, the FDA went even further and banned the use of Bayer’s Magnevist on patients with kidney problems, due to the heightened risk of NSF.
The agency also required label changes for all gadolinium agents, warning healthcare professionals to screen patients before injecting gadolinium to identify those suffering from acute kidney injury or chronic, severe kidney disease.
However, the new lawsuits, the most high profile of which was filed by actor and martial artist Chuck Norris on behalf of his wife, indicate that the plaintiffs or family members who suffered gadolinium poisoning suffered no reduced kidney function, raising questions as to whether the gadolinium contrast agent side effects are limited to those with kidney problems.
Recently, there have also been growing concerns over signs of gadolinium build-up in the body. In September, the FDA’s Medical Imaging Drugs Advisory Committee voted to recommend the FDA require new MRI contrast agent warnings about the risk of gadolinium build up in the brain. However, in May the FDA concluded that gadolinium in the brain appeared to carry no threat of health effects.
The FDA is continuing to assess their safety, and its National Center for Toxicological Research is currently conducting a study on gadolinium brain retention in rats.