Last week the European Medicines Agency (EMA) issued a final opinion confirming restrictions on the use of certain gadolinium agents in MRI body scanners and suspending the authorizations of others.
The European Medicines Agency (EMA) has concluded its scientific review of of gadolinium deposition in brain and other tissues, confirming recommendations to restrict the use of some linear gadolinium contrast agents used in MRI body scans and suspend the authorisations of others.
The recommendations – confirmed by EMA’s Committee for Medicinal
Products for Human Use (CHMP) – follow a review that found that
gadolinium deposition occurs in brain tissues following use of
gadolinium contrast agents.
While there is currently no evidence that gadolinium deposition in the brain has caused any harm to patients, EMA has however recommended restrictions for some intravenous linear agents in order to prevent any risks that could potentially be associated with gadolinium brain deposition.
The intravenous linear agents gadoxetic acid and gadobenic acid can
continue to be used for liver scans because they are taken up in the
liver and meet an important diagnostic need. In addition, gadopentetic
acid given intra-articularly (into the joint) can continue to be used
for joint scans because the dose of gadolinium used for joint injections
is very low.
All other intravenous linear products (gadodiamide, gadopentetic acid and gadoversetamide) should be suspended in the EU.
Another class of gadolinium agents known as macrocyclic agents
(gadobutrol, gadoteric acid and gadoteridol) are more stable and have a
lower propensity to release gadolinium than linear agents. These
products can continue to be used in their current indications but in the
lowest doses that enhance images sufficiently and only when unenhanced
body scans are not suitable.
The suspensions or restrictions on
linear agents can be lifted if the companies concerned provide evidence
of new benefits in an identified patient group that outweigh the risk of
brain deposition or if the companies can modify their products so they
do not release gadolinium significantly or cause its retention in
tissues.
EMA’s scientific review of gadolinium deposition in brain
and other tissues is now concluded. The final recommendations will be
sent to the European Commission, which will issue a final legally
binding decision applicable in all EU Member States.
Product
|
Type (formulation)
|
Recommendation
|
|
Artirem / Dotarem (gadoteric acid)
|
macrocyclic (i.v.)
|
maintain
|
|
Artirem / Dotarem (gadoteric acid)
|
macrocyclic (intra- articular)
|
maintain
|
|
Gadovist (gadobutrol)
|
macrocyclic (i.v.)
|
maintain
|
|
Magnevist (gadopentetic acid)
|
linear (i.v.) |
maintain
|
|
Magnevist (gadopentetic acid)
|
linear (i.v.)
|
suspend
|
|
Multihance (gadobenic acid)
|
linear (i.v.)
|
restrict use to liver scans
|
|
Omniscan (gadodiamide)
|
linear (i.v.)
|
suspend
|
|
Optimark (gadoversetamide)
|
linear (i.v.)
|
suspend
|
|
Primovist (gadoxeticacid)
|
linear (i.v.)
|
maintain
|
|
Prohance (gadoteridol)
|
macrocyclic (i.v.)
|
maintain
|
Source: EMA Press Release
Related information
EMA: Gadolinium-containing contrast agents
EMA: July 21, 2017: EMA’s final opinion confirms restrictions on use of linear gadolinium agents in body scans
EMA: July 7, 2017: PRAC confirms restrictions on the use of linear gadolinium agents
EMA:
March 10, 2017: PRAC concludes assessment of gadolinium agents used in
body scans and recommends regulatory actions, including suspension for
some marketing authorisations
EMA: March 8, 2016: PRAC reviews gadolinium contrast agents used in MRI scans
FDA: Information on Gadolinium-Based Contrast Agents
FDA:
July 27, 2015: FDA evaluating the risk of brain deposits with repeated
use of gadolinium-based contrast agents for magnetic resonance imaging
(MRI)
Related EVISA Resources
Brief summary: Speciation analysis for the study of metallodrugs and their biomolecular interactions
Link Database: Toxicity of Gadolinium compounds
Link Database: Use of Gadolinium in pharmaceuticals
Materials Database: Gadolinium Materials
Link page: All about Mass Spectrometry: Resources related to Mass Spectrometry
Related EVISA News
May 23, 2017: FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs
March 11, 2017: European Medicines Agency recomments to pull linear Gadolinium-based MRI contrast agents from market
April 10, 2016: New Studies Question Safety of MRI Contrast Agents
August 13, 2015: FDA investigating risk of gadolinium contrast agent brain deposits
March 4, 2015: Detection of Gd-based contrast agent in the skin of a patient eight years after administration
October 29, 2012: Identification and quantification of potential metabolites of Gd-based contrast agents
September 15, 2010: US FDA Announces Gadolinium-Based MRI Contrast Agent Warning
March 25, 2010: Publication on the separation of Gd-based contrast agents awarded
May 4, 2009: Gadolinium speciation analysis in search for the cause of nephrogenic systemic fibrosis (NSF)
last time modified: July 29, 2017
