Japan adopts new gadolinium use restrictions

Japan has adopted new restrictions on the use of linear gadolinium-based contrast agents (GBCAs), according to an editorial written by Dr. Tomonori Kanda of Kobe University and published online on March 16 in Magnetic Resonance in Medical Sciences.

The current Japanese market allows for use of both linear and macrocyclic GBCAs. But in November 2017, package inserts for GBCAs in Japan were revised to include the following two new recommendations:

  • Physicians should consider restricting GBCA use to clinical circumstances in which the information provided by the contrast is necessary.
  • Macrocyclic GBCAs are the primary choice; linear GBCAs should be used when macrocyclic agents are not indicated due to patient history of adverse effects (with the exception of linear agent gadoxetic acid).

These new recommendations mean that gadodiamide and gadopentetate dimeglumine (linear agents) can be used only in patients who had adverse effects from macrocyclic GBCAs, Kanda wrote.

"Although the risk of adverse effects due to gadolinium deposition in the brain is not proven, the use of linear gadolinium has been restricted in this revised package insert in view of the risk of possible adverse events in the future," he concluded.

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