EMA's final opinion confirms restrictions on use of linear gadolinium agents in body scans
Press release
Human
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, Gadolinium Article-31 referral – PRAC confirms restrictions on the use of linear gadolinium agents 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 (gadoxetic acid) | linear (i.v.) | maintain |
Prohance (gadoteridol) | macrocyclic (i.v.) | maintain |
Information for patients
Information for healthcare professionals
More about the medicines
Gadolinium contrast agents are used as contrast enhancers to improve image quality with magnetic resonance scans. These body scans rely on the magnetic fields produced by water molecules in the body. Once injected, gadolinium interacts with the water molecules. As a result of this interaction, the water molecules give a stronger signal, helping to obtain a brighter image.
This review covers agents containing the following active substances: gadobenic acid, gadobutrol, gadodiamide, gadopentetic acid, gadoteric acid, gadoteridol, gadoversetamide and gadoxetic acid.
Most gadolinium-containing contrast agents have been authorised nationally in the EU. OptiMARK (gadoversetamide) is the only gadolinium contrast agent that was authorised centrally via EMA in the EU.
More about the procedure
The review of gadolinium contrast agents was initiated on 17 March 2016 at the request of the European Commission, under Article 31 of Directive 2001/83/EC.
The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations in March 2017.
Following a request from companies concerned, the PRAC re-examined its initial recommendation. The PRAC's final recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which has adopted the Agency's final opinion.
The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.