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KMID : 1011320190110020072
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Journal of Pharmacoepidemiology and Risk Management
2019 Volume.11 No. 2 p.72 ~ p.83
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Gadolinium Presence in the Brain: Current Understanding Based on Clinical Observations and Non-clinical Evidences
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Cho In-Su
Won Kyung-Soo
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Abstract
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In 2014, a study regarding repeated injection of gadolinium-based contrast agent (GBCA) and increased signal intensity (SI) in specific brain regions of unenhanced T1-weighted magnetic resonance imaging was published. Although many follow-up studies support these observations, no studies or reports have confirmed the association of increased SI with repeated administration of GBCA to specific clinical abnormalities. However, in November 2017, the European Commission in line with European Medicines Agency (EMA)’s decision suspended the use of linear gadolinium contrast agent as preemptive precautions, and in December 2017, the US Food and Drug Administration (FDA) has taken steps to keep all gadolinium contrast agents maintained, but to update safety information on all products. In Korea, the Ministry of Food and Drug Safety (MFDS) also continuously announced Dear Healthcare Professionals letters, observing the progression by EMA and FDA. Eventually, MFDS in March 2018, changed the regulatory permission to use macrocyclic-GBCAs only over linear-GBCAs following the EMA standards, and as of now in 2019, all supply of linear GBCAs were ceased in Korea. This article examines the clinical and nonclinical findings to date to support these regulatory decisions and presents a general review in Korean that sums current understandings in evaluating the clinical usefulness of gadolinium-containing MR contrast agents based on the scientific evidences.
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KEYWORD
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Gadolinium, Signal intensity increase, Gadolinium-based MR contrast agents (GBCA
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