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EMA confirms restrictions on gadolinium agents in MRI scans

Thursday 13th July 2017
The European Medicines Agency has confirmed restrictions on the use of certain gadolinium agents in MRI scans. Image credit: Wavebreakmedia via iStock.
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The European Medicines Agency (EMA) has announced restrictions on certain gadolinium contrast agents that are used to enhance images from MRI body scans.

This official confirmation follows the announcement in March 2017 that the EMA's Pharmacovigilance and Risk Assessment Committee (PRAC) had recommended the suspension of marketing authorisations for the agents.

The agents in question include gadobenic acid (Multihance), gadodiamide (Omniscan), gadopentetic acid (Magnevist) and gadoversetamide (OptiMARK), which are administered to patients via intravenous injection.

Concerns were raised after the PRAC conducted a review which found evidence of gadolinium deposits in the brain after MRI body scans, but no signs of harm.

The final recommendations are for use of gadodiamide, gadopentetic acid and gadoversetamide to be suspended.

Gadobenic acid and gadoxetic acid (Primovist) should now only be used for liver scans, in instances where these agents are required to meet a significant diagnostic need.

The PRAC also concluded that gadopentetic acid should only be used for joint scans, after the investigation found that the concentration of gadolinium used for joint injections is very low.

Macrocyclic agents assessed in the review - namely gadobutrol (Gadovist), gadoteric acid (Dotarem) and gadoteridol (ProHance) - were found to be more stable, with a lower risk of releasing gadolinium than linear agents.

As a result, these can continue to be used in current indications, but only in the lowest possible doses to enhance MRI imagery and when unenhanced scans are not suitable.

The next step will be for the PRAC's recommendations to be passed on to the Committee for Medicinal Products for Human Use, which will adopt the agency's final opinion.

Another current issue for radiographers in the UK to be aware of is MRI capacity across the NHS, with MRI departments being advised to formulate plans to replace outdated equipment.

The Clinical Imaging Board - a collaboration between the Society and College of Radiographers, the Royal College of Radiologists and the Institute of Physics and Engineering in Medicine - collected data relating to 171 scanners across the UK and found that 29 per cent of MRI systems are at least ten years old.

Written by Alex Franklin Stortford

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