11 Jul, 2017

PRAC confirms restrictions on the use of linear gadolinium agents

At a recent meeting, EMA´s committee for pharmacovigilance risk assessment (PRAC) confirmed their position from March 2017 that there are evidence of gadolinium deposition in the brain following use of Gd-contrast agents for MRI.

PRAC maintains their recommendation to suspend the commercially available contrast agents Optimark (Guerbet), Omniscan (GE Healthcare) and Magnevist (Bayer). For MultiHance (Bracco) and Eovist/Primovist (Bayer) the committee recommend they only be used for liver imaging in situations where there is an important diagnostic need.

The committee further recommend that the contrast agents Dotarem (Guerbet), Gadovist (Bayer), ProHance (Bracco) andClariscan (GE Healthcare) are used at lowest possible dose in situations where unenhanced images are not suitable.

For further info, see EMA release.