The European Commission has suspended the sale of certain products for intravenous injection of linear gadolinium contrast agent used in brain and spine magnetic resonance imaging (MRI) tests on Nov. 23.
The suspension follows a review that found that gadolinium deposition occurs in brain tissues following the use of gadolinium contrast agents.
“There is currently no evidence that gadolinium deposition in the brain has caused any harm to patients,” said the European Medicine Agency in a statement on linear gadolinium contrast agents. “However EMA has recommended restrictions for some intravenous linear agents to prevent any risks that could potentially be associated with gadolinium brain deposition.”
Suspended for intravenous injection of linear gadolinium contrast agents are gadodiamide, gadoversetamide and gadopentetic acid.
The suspensions or restrictions on linear agents can be lifted if the companies concerned provide evidence of new benefits in an identified patient group that outweigh the risk of brain deposition or if the companies can modify their products, so they do not release gadolinium significantly or cause its retention in tissues, the statement added.
On Friday, the Ministry of Food and Drug Safety 식품의약품안전처 notified related professionals, such as doctors and pharmacists, of the suspension and advised caution when using linear gadolinium contrast agents on patients. The ministry also plans to review the current status of linear gadolinium contrast agents in Korea and overseas and take necessary safety measures through consultation with experts.
There are 15 products from nine companies approved by the ministry for intravenous injection of linear gadolinium contrast agent used in MRI. However, only 10 of the products produced sales records this year.
|Linear gadolinium contrast agent sold in 2016.|
Although EMA has suspended sales of linear gadolinium contrast agents, the U.S. Food and Drug Administration (FDA) and the Japanese Ministry of Health, Labor and Welfare have continued to sell linear gadolinium contrast agents after their research did not confirm any adverse effects regarding gadolinium deposition in the brain.
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