GUERBET : Gadolinium-based contrast agents: update on MHLW decision in Japan
December 06 2017 - 12:05PM
Villepinte (France), December 6, 2017 (6pm
CET) - Guerbet (FR0000032526 GBT), a global specialist in
contrast agents and solutions for medical imaging, takes note of
the decision issued on November 28 by the Japanese Ministry of
Health, Labour and Welfare (MHLW), regarding the mandatory revision
of the precautions section in the package insert of
gadolinium-based contrast agents (GBCAs), with immediate
effect.
In parallel to the European Commission's
decision to suspend the use of non-specific linear gadolinium
agents in body scans, the MHLW has decided to restrict the use of
non-specific linear GBCAs only in cases where there is no
alternative, based on the "higher Gadolinium accumulation in brain
reported with these linear agents".
For all GBCAs, "the necessity of MRI scan
using gadolinium-based contrast agents should be determined
carefully" as stated in the Japanese new package insert.
Magnetic resonance imaging (MRI) is a widely
used diagnostic procedure which is critical to patient health and
contrast enhanced MRI exams are vital to give physicians a sharper,
more accurate picture of tissue than they would otherwise be able
to have.
There are two kinds of gadolinium based contrast
agents (GBCAs), linear and macrocyclic. Although there are many
similarities amongst these agents, they differ in their kinetic and
thermodynamic stability. Linear GBCAs are generally less stable,
and for this reason, more likely than macrocyclic agents to deposit
gadolinium in tissue. Guerbet's GBCA, Dotarem®, distributed under
the brand name Magnescope® (Meglumine gadoterate) in Japan, is a
macrocyclic agent.
Revision of precautions for Linear
GdCAs:*"1. It has been reported that high signal intensity was
observed in the cerebellar dentate nucleus and globus pallidus on
unenhanced T1-weighted MR images and that gadolinium was detected
in autopsied brain tissues in patients who received a
gadolinium-based contrast agent several times. The necessity of MRI
scan using gadolinium-based contrast agents should be determined
carefully.2. It has been reported that more gadolinium remained in
the brain with linear gadolinium-based contrast agents containing
this drug than with macrocyclic gadolinium-based contrast agents.
This drug should be administered when macrocyclic gadolinium-based
contrast agents are not appropriate."
Revision of precautions for Macrocyclic
GdCAs:*"It has been reported that high signal intensity was
observed in the cerebellar dentate nucleus and globus pallidus on
unenhanced T1-weighted MR images and that gadolinium was detected
in autopsied brain tissues in patients who received a
gadolinium-based contrast agent several times. The necessity of MRI
scan using gadolinium-based contrast agents should be determined
carefully."
"Following the European and Japanese Health Agencies decisions
regarding the evolution of label changes for linear and for
macrocyclic GBCAs, other important regulatory positions are
expected soon" said Pierre Desché, Development, Medical &
Regulatory Affairs Vice President.
In the meantime, Guerbet has immediately
proceeded to the requested revision of precautions for Magnescope®
and will continue to work with Health Authorities to further
understand the mechanisms and consequences of gadolinium deposition
in tissue.
* English version on the Revision of precautions
for Linear GBCAS and for Macrocyclic GBCAs are published in PMDA-HP
http://www.pmda.go.jp/english/safety/info-services/drugs/revision-of-precautions/0005.html.
About Guerbet
Guerbet is a pioneer in the contrast-agent
field, with more than 90 years' experience, and is a leader in
medical imaging worldwide. It offers a comprehensive range of
pharmaceutical products, medical devices and services for x-ray
scans, magnetic resonance imaging (MRI) and interventional
radiology and theranostics (IRT), to improve the diagnosis and
treatment of patients. With 7% of revenue dedicated to R&D and
more than 200 employees distributed amongst its three centers in
France and the United States, Guerbet is a substantial investor in
research and innovation. Guerbet (GBT) is listed on Euronext Paris
(segment B - mid caps) and generated €776 million in revenue in
2016. For more information about Guerbet, visit www.guerbet.com
Media relations
Guerbet Global Alize RP Caroline Carmagnol and Wendy
Rigal +33 (0)1 44 54 36 66 /
+33 (0)6 48 82 18 94
guerbet@alizerp.com |
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