UK’s Medicines and Healthcare products Regulatory Agency has announced that it will remove two gadolinium-based contrast agents (GBCAs) from the market in the wake of a review that found some patients are at risk of retaining the heavy-metal. The announcement was made on December 14, 2017, and will take effect February 1, 2018. Meanwhile, other gadolinium contrast agents will have their use limited.
According to the agency, a review found that “low levels of gadolinium can be retained in the brain and other tissues after administration of gadolinium-containing contrast agents.” As a result, the licenses for Omniscan and Magnevist will be suspended and the products will be subject to recall. MultiHance and Primovist will be limited to “delayed phase liver imaging only.” All contrast agents affected by the announcement are considered linear agents, which are most strongly linked to gadolinium retention.
Physicians Expected to Use Alternative Products
In its advice for healthcare professionals, the agency notes that gadolinium-based dyes should only be used when the diagnostic information is essential and cannot be obtained except through the use of a dye. Furthermore, healthcare professionals are expected to have switched to alternative gadolinium-based contrast agents by February 1, 2018.
Macrocyclic agents, such as Prohance, Gadovist, and Dotarem, are still authorized for use with MRIs.
Review Found Evidence of Gadolinium Retention
Following a review on gadolinium retention, the agency noted that “Low levels of gadolinium deposition in the brain, particularly in the dentate nucleus of the cerebellum and in the sub-cortical structure the globus pallidus, have been confirmed by mass spectrometry and studies of MRI data.”
The European agency also noted that studies suggested macrocyclic agents are less likely to cause gadolinium retention because they are more stable. That stability prevents gadolinium from being released into the patient’s body.
As a result of the review, the agency concluded that “the risks of gadodiamide and intravenous gadopentetic acid are considered to outweigh their benefits.”
Agency’s Move Follows European Medicines Agency Recommendations
In July 2017, the European Medicines Agency (EMA) concluded its review of gadolinium-based contrast agents and recommended that the use of some such agents be suspended while others have their use limited. When it made its recommendations, the EMA noted that the suspensions or restrictions could be lifted if the manufacturers provided evidence of patient groups that would benefit from the use of those agents.
The EMA advised healthcare professionals to only use the lowest CGBA dose required to obtain a clear image.
U.S. FDA Issues Warnings, No Recall
Despite issuing updated warnings about the risk of gadolinium side effects–including gadolinium retention–linked to GBCAs, the U.S. Food and Drug Administration (FDA) has so far not announced a recall of the contrast agents, still claiming that the benefits of GBCAs outweigh the risks.
In its announcement of an updated warning, the FDA noted that all gadolinium-based contrast agents would be required to carry a warning that the gadolinium could potentially remain in the patient’s tissues, including the brain, for a period of months to years after being administered.
Gadolinium Lawsuits Filed
Gadolinium lawsuits have been filed against the makers of the contrast agents, alleging patients were not properly warned about that risk. Of those, the most high profile is the lawsuit filed by Chuck and Gena Norris, alleging Gena Norris, Chuck Norris’ wife, suffered serious and debilitating gadolinium side effects.
In addition to representing Chuck and Gena Norris, Cutter Law filed the first gadolinium lawsuit regarding gadolinium deposition disease and has filed numerous lawsuits since. If you or a loved one has been affected by the use of gadolinium, contact an attorney at Cutter Law to discuss your legal options. Our attorneys are highly experienced in gadolinium litigation and will advocate for your rights.