The U.S. Food & Drug Administration (FDA) has approved new Medication Guides for gadolinium-based MRI contrast agents, amid growing concerns that gadolinium deposits can remain in the body, potentially resulting in serious adverse effects.
In a Drug Safety Communication updated on May 16th, the FDA indicated that MRI centers should provide the new Medication Guides to patients undergoing gadolinium-based imaging screens for the first time.
“In general, hospital inpatients are not required to receive a Medication Guide unless the patient or caregiver requests it,” the agency state. “A health care professional who determines that it is not in a patient’s best interest to receive a Medication Guide because of significant concerns about its effects may direct that it not be provided to that patient; however, the Medication Guide should be provided to any patient who requests the information.”
Gadolinium is a heavy metal used in MRI contrast agents, including:
In December 2017, the FDA announced a new class warning regarding the risk that gadolinium could be retained in a patient’s body, including the brain, long after an MRI. In addition to requiring a new Medication Guide, the agency also ordered the manufacturers of gadolinium contrast agents to conduct human and animal studies to further assess the safety of these drugs.
“To date, the only known adverse health effect related to gadolinium retention is a rare condition called nephrogenic systemic fibrosis (NSF) that occurs in a small subgroup of patients with pre-existing kidney failure,” the FDA said. “We have also received reports of adverse events involving multiple organ systems in patients with normal kidney function. A causal association between these adverse events and gadolinium retention could not be established.”
Of the two types of gadolinium-based contrast agents —linear and macrocyclic— linear agents have greater and longer retention compared to macrocyclic agents. Linear gadolinium agents include Eovist, Magnevist, MultiHance, Omniscan and OptiMark.
The FDA indicated that gadolinium levels retained in the body are higher after receiving Omniscan or Optimark (compared with Eovist, Magnevist, or MultiHance). The lowest levels of retained gadolinium were associated with Dotarem, Gadavist, and ProHance.
Though gadolinium retention has not been directly linked to adverse events in patients with normal kidney function, the FDA has advised healthcare providers to consider the retention characteristics of each agent when choosing a gadolinium product for patients who may be at higher risk for retention, including:
Patients, parents and caregivers should carefully read the gadolinium Medication Guide before undergoing an MRI. They should also be sure to tell their healthcare provider about all of their medical conditions, including:
In recent months, a growing number of gadolinium toxicity lawsuits have been filed in U.S. courts on behalf of patients who suffered adverse events allegedly linked to the retention of gadolinium following an MRI.
Though Gadolinium Deposition Disease (GDD) is not currently recognized by the FDA or the medical community, plaintiffs contend that gadolinium retention is causing a wide range of symptoms in patients with normal kidney function, including:
Plaintiffs further claim that these complications could have been avoided had the drugs’ manufacturers not failed to warn the public about the risks allegedly associated with gadolinium retention.