EMA Final Opinion Confirms Gadolinium Restrictions

Megan Brooks

Disclosures

July 21, 2017

The European Medicines Agency (EMA) has concluded its review of gadolinium contrast agents, confirming earlier recommendations to restrict the use of some linear gadolinium agents used in MRI and suspend the authorizations of others.

Gadolinium is a heavy metal that can be retained not only in the brain but also in bone and skin. Gadolinium-based contrast agents have linear or macrocyclic chemical structures.

The EMA's final recommendations follow a review that found that gadolinium deposition does occur in brain tissues following use of gadolinium contrast agents.

"There is currently no evidence that gadolinium deposition in the brain has caused any harm to patients; however EMA has recommended restrictions for some intravenous linear agents in order to prevent any risks that could potentially be associated with gadolinium brain deposition," the EMA said in a July 21 news release

The EMA said two intravenous linear agents — gadoxetic acid and gadobenic acid — will remain available as these agents undergo hepatic uptake and can be used for imaging poorly vascularized hepatic lesions, especially in delayed-phase imaging, that cannot be adequately studied with other agents.

Intra-articular formulations of the linear agent gadopentetic acid will also continue to be available because the dose of gadolinium that is required for these scans is very low. All macrocyclic agents reviewed — gadobutrol, gadoteric acid, and gadoteridol — will also remain available.

"Healthcare professionals should use gadolinium contrast agents only when essential diagnostic information cannot be obtained with unenhanced scans. Healthcare professionals should always use the lowest dose that provides sufficient enhancement for diagnosis," the EMA advised.

The product information for gadolinium contrast agents remaining on the market in the European Union will be updated with this new information and healthcare professionals in the EU will also receive a letter with information about the EMA review of gadolinium contrast agents and final opinion.

The EMA said the suspensions or restrictions on linear agents can be lifted if manufacturers provide "evidence of new benefits in an identified patient group that outweigh the risk of brain deposition or if the companies can modify their products so they do not release gadolinium significantly or cause its retention in tissues," the EMA said.

Thus far, the US Food and Drug Administration (FDA) has taken a different stance on gadolinium-based contrast agents, as reported by Medscape Medical News in May of this year.

After a 2-year study, the agency found no evidence of adverse events from the brain's retention of gadolinium after MRI that uses these agents.  Accordingly, the FDA said in May that it would not restrict the use of gadolinium contrast agents. However, it said it will continue to study their safety and urged clinicians to use these agents sparingly.

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