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MFDS revises warning label for 25 gadolinium-based contrast agent products
  • By Marian Chu
  • Published 2018.02.28 17:51
  • Updated 2018.02.28 17:51
  • comments 0

The Ministry of Food and Drug Safety said it would revise the warning labels for eight types of gadolinium-based contrast agents (GBCAs), encompassing a total of 25 such products. The label changes will go into effect on Mar. 15.

“Our ministry examined the safety information of GBCAs by comprehensively examining the status domestically and abroad, counsel from the central drug evaluation committee, and opinions submitted by firms and decided to create the revisions,” the ministry said in its posting.

In December, the U.S. Food and Drug Administration required several actions that involve alerting healthcare professionals and patients about the accumulation of gadolinium in the brain after getting an MRI using a GBCA. But the FDA noted that the benefits of approved GBCAs still outweigh potential risks, clarifying that the only adverse health effect related to gadolinium buildup is a rare condition called nephrogenic systemic fibrosis (NSF).

The ministry’s latest warning label for one of the GBCA types called Gadobutrol notes observations of high-intensity signals in a sub-cortical structure of the brain called globus pallidus and the cerebellar dentate nucleus in T1-weighted MRI images of patients who had multiple GBCA injections.

It also calls for “careful discretion” when considering using MRIs with GBCAs, considering the lack of clinical results.

The respective revisions will be applied to the eight types GBCAs, and specifically to the contrast agents developed by Bracco Imaging Korea, GE Healthcare AS Korea, Bayer Korea, Taejoon Pharm, Guerbet Korea, Dai Han Pharm, Dongkook Pharmaceutical, Imaging Solutions Korea, and Dasol Life Science.

GBCAs are used in diagnostic MRIs in adults and children to highlight areas in the central nervous system that have disrupted blood-brain barriers (BBB) or abnormal vascularity. It also works to expose the presence of breast disease, and detect stroke and tumor perfusion.

yjc@docdocdoc.co.kr

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