Side effects associated with gadolinium-based MRI dyes and other contrast agents can cause allergy-like reactions in some children.
While most of these children will experience mild symptoms, a study recently published in Pediatric Radiology reports that roughly 20% will present with more severe – possibly even life-threatening — reactions, including diffuse edema, anaphylactic shock, and pulmonary edema.
In some case, children exposed to MRI contrast dyes may develop physiological problems that range from mild headaches, dizziness, and nausea to more serious hypertensive emergencies, seizures, and arrhythmia.
“Physiological reactions are more common than allergic-like reactions, are usually transient and generally require only supportive care,: the study authors wrote. “It is our obligation as radiologists supervising the administration of contrast material to be capable of both recognizing and treating such contrast reactions.”
Gadolinium-based MRI contrast dyes are injected prior to an MRI to enhance the appearance of tissue, organs, blood vessels and other images on a scan.
The U.S. Food& Drug Administration (FDA) has approved 8 gadolinium contrast dyes, including the following linear agents:
The remaining 3 are classified as macrocylic agents:
In May 2007, the FDA ordered the manufacturers of gadolinium-based MRI contrast dyes to add a Black Box Warning – the strongest warning possible – to their product labels regarding Nephrogenic Systemic Fibrosis (NSF), a debilitating and life-threatening disorder that can occur in kidney-impaired patients who have been administered gadolinium agents.
Until recently, it was believed gadolinium was eliminated from the body fairly quickly in patients with healthy kidneys. In December 2017, however, the FDA ordered another label modification, after several studies suggested that gadolinium deposits could remain in the brain and other organs long after an MRI, even in patients with normal kidney function. The highest risk of retention was associated with linear gadolinium agents.
So far, the FDA has not linked gadolinium retention to any adverse events. Even so, the agency has advised health care professionals to consider the retention characteristics of each agent when choosing a gadolinium product for patients who may be at higher risk for retention, including:
In addition, the FDA ordered manufacturers of gadolinium-based contrast dyes to conduct animal and human studies to better evaluate their safety.
Hundreds of people took legal action after the FDA added the NSF warning to gadolinium labels in 2007. That litigation has been resolved, as most plaintiffs were able to reach highly-favorable settlements with the drugs’ manufacturers.
Over the past year, dozens of news cases have been filed on behalf of individuals who allegedly developed “Gadolinium Deposition Disease” following an MRI.
According to these lawsuits, plaintiffs had normal kidney function when they underwent MRIs with gadolinium-based agents. As a result of gadolinium retention, they developed one or more of the following side effects.
The U.S. Judicial Panel on Multidistrict Litigation (JPML) recently rejected a plaintiffs’ petition to centralize gadolinium retention lawsuits in a single federal court for the purpose of coordinated discovery and other pretrial proceedings.
The litigation is far from over, however, as all federally-filed gadolinium-based MRI contrast dye lawsuits will continue to move forward on an individual basis. Plaintiffs may renew their centralization request if they are able to overcome the JPML’s objections.