EMA confirms restrictions on use of linear gadolinium agents

Published: 11 July 2017 Ezine

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:

  • Gadobenic acid (Multihance) and gadoxetic acid (Primovist) should only be used for liver scans in the situations where they meet an important diagnostic need.
  • Gadopentetic acid (Magnevist) should only be used for joint scans as the gadolinium concentration in the formulation used for joint injections is very low.
  • All other intravenous linear agents, gadodiamide (Omniscan), gadopentetic acid (Magnevist) and gadoversetamide (OptiMARK) should be suspended in line with the PRAC’s March 2017 recommendation.

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.

Find our more on the EMA website.