Petition update

Japanese Government Follows European Union Decision Regarding Limitation of Gadolinium Use

MedInsight Research Institute

Dec 11, 2017 — On November 28, 2017, The Japanese Ministry of Health, Labour and Welfare made the decision to suspend the use of non-specific linear gadolinium agents in MRI scans. The decision comes on the heels of the European Union’s recent similar change in policy.

Based on the higher gadolinium accumulation in the brain reported with these agents, Japan and the European Union are now restricting their use, only for cases where there is no alternative. In addition, the Japanese Ministry stated that “the necessity of MRI scan using gadolinium-based contrast agents should be determined carefully” and is now stated in the new Japanese package insert.

The package insert revision reads as follows:

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.

There are two types of gadolinium-based contrast agents, linear and macrocyclic. As linear agents are less stable, they are more likely to deposit in body tissues.

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