The European Medicines Agency (EMA) recently announced it is taking regulatory action on certain magnetic resonance imaging (MRI) contrast drugs containing gadolinium a couple of months after the U.S. Food and Drug Administration (FDA) decided otherwise.
We start with the timeline of events giving rise to the EMA’s suspension of the MRI drugs Magnevist, Omniscan, and OptiMARK in July 2017.
In this July 7, 2017 EMA document, “PRAC confirms restrictions on the use of linear gadolinium agents”, which included this statement: “No specific conditions linked to gadolinium deposition in the brain have been identified, but the clinical consequences are unknown.”
And in its July 21, 2017 document, “EMA’s final opinion confirms restrictions on use of linear gadolinium agents in body scans”, we get this further elaboration on that statement:
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….
We turn now to the FDA’s treatment of this drug-safety assessment of Magnevist, Omniscan, and OptiMARK, as well as the several other gadolinium-based contrast agents (GBCAs).
From its “FDA Drug Safety Communication: FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continue” we get this explanation of why no regulatory action is necessary — at least not yet:
All GBCAs may be associated with some gadolinium retention in the brain and other body tissues. However, because we identified no evidence to date that gadolinium retention in the brain from any of the GBCAs, including GBCAs associated with higher retention of gadolinium, is harmful, restricting GBCA use is not warranted at this time. We will continue to assess the safety of GBCAs and plan to have a public meeting to discuss this issue in the future….
We will be watching for the “public meeting to discuss this issue in the future” mentioned by the FDA — which, perhaps, will be a so-called Advisory Committee Meeting.
In addition, we will monitor the medical literature for “any risks that could potentially be associated with gadolinium brain deposition” mentioned by the EMA.