EMA’s final opinion confirms restrictions on use of linear gadolinium agents in body scans
Recommendations conclude EMA’s scientific review of gadolinium deposition in brain and other tissues
The European Medicines Agency (EMA) has concluded its review of gadolinium contrast agents, confirming recommendations to restrict the use of some linear gadolinium agents used in MRI body scans and suspend the authorisations of others.
The recommendations – confirmed by EMA’s Committee for Medicinal Products for Human Use (CHMP) – follow a review that found that gadolinium deposition occurs 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 intravenous linear agents gadoxetic acid and gadobenic acid can continue to be used for liver scans because they are taken up in the liver and meet an important diagnostic need. In addition, gadopentetic acid given intra-articularly (into the joint) can continue to be used for joint scans because the dose of gadolinium used for joint injections is very low.
All other intravenous linear products (gadodiamide, gadopentetic acid and gadoversetamide) should be suspended in the EU.
Another class of gadolinium agents known as macrocyclic agents (gadobutrol, gadoteric acid and gadoteridol) are more stable and have a lower propensity to release gadolinium than linear agents. These products can continue to be used in their current indications but in the lowest doses that enhance images sufficiently and only when unenhanced body scans are not suitable.
The suspensions or restrictions on linear agents can be lifted if the companies concerned 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.
EMA’s scientific review of gadolinium deposition in brain and other tissues is now concluded. The final recommendations will be sent to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.
Product Type (formulation) Recommendation
Artirem / Dotarem (gadoteric acid)macrocyclic (i.v.) maintain
Artirem / Dotarem (gadoteric acid)macrocyclic (intra-articular) maintain
Gadovist (gadobutrol) macrocyclic (i.v.) maintain
Magnevist (gadopentetic acid) linear (intra-articular) maintain
Magnevist (gadopentetic acid) linear (i.v.) suspend
Multihance (gadobenic acid) linear (i.v.) restrict use to liver scans
Omniscan (gadodiamide) linear (i.v.) suspend
Optimark (gadoversetamide) linear (i.v.) suspend
Primovist (gadoxeticacid) linear (i.v.) maintain
Prohance (gadoteridol) macrocyclic (i.v.) maintain
Gadolinium Article-31 referral – EMA’s final opinion confirms restrictions on use of linear gadolinium agents in body scans