There is a difference between the United States FDA and the United Kingdom MHRA in terms of the regulatory actions being taken with respect gadolinium-based contrast agents (GBCAs).
The drug safety issue is that low levels of gadolinium can be retained in the brain and other tissuesfor months to years after the administration of these drugs for magnetic resonance imaging (MRI).
On December 14, 2017 the Medicines and Healthcare products Regulatory Agency (MHRA) issued this document, “Gadolinium-containing contrast agents: removal of Omniscan and iv Magnevist, restrictions to the use of other linear agents”, which includes the following statement:
There is currently no evidence that gadolinium deposition in the brain has caused adverse neurological effects in patients; however, licences for gadodiamide (Omniscan) and intravenous gadopentetic acid (also known as gadopentetate dimegulumine; Magnevist) will be suspended from 1 February 2018 and these products will be recalled.
Further, this MHRA document points out that “One linear agent, gadoversetamide (OptiMARK), has been withdrawn by the Marketing Authorisation Holder and is not available in the UK.”
In comparison, at the present time FDA is only requiring that there be certain changes made to the Prescribing Information, or drug label, of all gadolinium-based contrast agents (GBCAs)
From the December 2017 “FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings”:
… A causal association between these adverse events and gadolinium retention could not be established.
We are continuing to assess the health effects of gadolinium retention in the body and will update the public when new information becomes available….
Accordingly, we will be watching for any future label changes or regulatory actions for gadolinium-based contrast agents, especially Magnevist, Omniscan, and OptiMARK, here in the US.
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