In Comparison, This December 2017 Regulatory Action By FDA In The US: "new class warning... for all gadolinium-based contrast agents"
There seems to be a consensus among the United States FDA and the United Kingdom MHRA drug safety agencies that low levels of gadolinium can be retained in the brain and other tissues after administration of gadolinium-based contrast agents (GBCAs) for months to years after receiving these drugs.
Another point of agreement between those agencies is that certain linear GBCAs -- such as Magnevist, Omniscan, and OptiMARK -- result in more gadolinium retention in the body than macrocyclic GBCAs.
There is a difference, however, between FDA and MHRA in terms of the regulatory actions being taken with respect to this class of drugs, now.
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Further, this MHRA document points out that "One linear agent, gadoversetamide (OptiMARK), has been withdrawn by the Marketing Authorisation Holder and is not available in the UK."
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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) for magnetic resonance imaging (MRI) in the US. To be clear, none of these products will be recalled from the market here.
On December 19, 2017 this document was issued, "FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings".
This document is an update to the May 22, 2017 MedWatch safety alert "Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - No Harmful Effects Identified With Brain Retention".
From the December 2017 FDA Drug Safety Communication:
To date, the only known adverse health effect related to gadolinium retention is a rare condition called nephrogenic systemic fibrosis (NSF) that occurs in a small subgroup of patients with pre-existing kidney failure. We have also received reports of adverse events involving multiple organ systems in patients with normal kidney function. 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 recommendations from the FDA's Medical Imaging Drugs Advisory Committee about further label changes or regulatory actions for gadolinium-based contrast agents, especially Magnevist, Omniscan, and OptiMARK, here in the US.
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