The government said it would ban 13 linear gadolinium contrast agents used for magnetic resonance imaging (MRI) tests until the end of this year.
The Ministry of Food and Drug Safety’s ban came after Europe suspended the sales of the drug because of the possibility of accumulation of the gadolinium contrast medium 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.
There are two types of gadolinium contrast agents depending on the structure – linear and macrocyclic.
Last year, the European Commission suspended the sales of some linear gadolinium contrast agents used for MRI tests for brain and spine, citing potential accumulation in the brain as the reason.
The EC’s sales ban came with one-year grace period depending on each country’s situation.
In many other countries, including the U.S., Canada, Japan, and Switzerland, linear gadolinium contrast agents are still available.
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).
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