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South Korea: 13 gadolinium contrast agents banned until year-end

(29.08.2018)


Background:

There are two types of gadolinium contrast agents (GBCAs) in use, which differ in their complex structure – linear and macrocyclic. Apart from their structure these two types of GBCAs also differ in their complex stability. Most macrocyclic complexes are more stable with respect to thermodynamic stability as well as kinetic exchange rate in comparison to linear complexes.  Because of their poorer stabily linear complexes are believed to be more prone to dechalation and transmetallation leading to the release of toxic gadolinium from the complex. Also linear complexes were retained in the patient bodies to a higher degree than macrocyclic ones, especially in the skin but also in the brain. In order to address potential health risks related to such retention, the European Commission suspended the sales of some linear gadolinium contrast agents used for MRI tests for brain and spine last year.


The Korean ban:

The Ministry of Food and Drug Safety’s (MFDS) ban came after Europe suspended the sales of the drug because of its retention in the brain. The ministry sent a Dear Healthcare Professional Letter (DHCPL) that it would discontinue the supply of 13 linear gadolinium contrast agents containing gadodiamide, gadopentetic acid, and gadoversetamide until the end of 2018. The ministry released the DHCPL in November last year and May. In March, it ordered to add a precaution to approval condition of gadolinium contrast agents that they could build up in the brain.

Recently, the government surveyed approval status in and out of the country, adverse drug events, and the drug use. Based on the consultation with the Central Pharmaceutical Affairs Committee, the ministry agreed with the suppliers of gadolinium contrast agents to suspend the local supply of the products until this year.

The suspended products are 13 linear gadolinium contrast agents containing gadoversetamide, gadodiamide, and gadopentetic acid. Gadoversetamide-using drugs are Imaging Solution Korea’s Optimark Plastic Syringe Injection and Optimark Injection. Gadodiamide agents are GE Healthcare’s Omniscan PFS Injection, Omniscan Injection, and Dai Han Pharm’s BONO-A Injection. Gadopentetic acid agents include Dai Han Pharm’s BONO-I Prefilled Injection, BONO-I Injection, and Dongkook Pharm’s Megaray Injection, Megaray Prefilled Syringe Injection, Bayer Korea’s Magnevist Injection, Taejoon Pharm’s MR Bester Prefilled Syringe Injection, MR Bester Injection (voluntary withdrawal of approval), and Dasol Life Science’s MR-lux Injection (patent expired on April 23, 2018).

In many other countries, including the U.S., Canada, Japan, and Switzerland, linear gadolinium contrast agents are still available.




Related information

EMA: European Medicines Agency. Gadolinium-containing contrast 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)



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last time modified: August 29, 2018










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