GUERBET : Gadolinium-based contrast agents: update on MHLW decision in Japan
December 06 2017 - 12:04PM
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.
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
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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Source: GUERBET via Globenewswire
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