The European Medicines Agency (EMA) has confirmed the restriction of the use of gadolinium agents following its previous recommendation in March 2017.
This follows a review of the products undertaken at the request of companies concerned.
The Agency’s Pharmacovigilance and Risk Assessment Committee (PRAC) recommends that:
PRAC states that macrocyclic agents gadobutrol (Gadovist), gadoteric acid (Dotarem) and gadoteridol (ProHance) are more stable and have a lower propensity to release gadolinium than linear agents.
These 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 PRAC’s recommendation will now be sent to the Committee for Medicinal Products for Human Use (CHMP), which will adopt the Agency’s final opinion.