Following the numerous studies published in 2015 on the hypersignals in the dentate nucleus and globus pallidus in patients having received several doses of Gd chelates, a major safety concern on MRI contrast agents has again emerged. In January 2016, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) reviewed these publications. Although no adverse effects relating to gadolinium brain deposition have been reported to date, the PRAC will carry out an in-depth review of the risk of brain deposits and of the overall safety of these products.
First discussions at the PRAC are expected to take place in June 2016.
Hopefully the final conclusions will give insights on the exact pharmacokinetics in brain, bone or other reservoir locations and allow clear recommendations for the clinical use.