South Korea Restricts Gadolinium Use Over Safety Concerns

South Korea Restricts Gadolinium Use Over Safety Concerns

Introduction

Health Regulators in South Korea declared a temporary ban on Linear gadolinium agents as lawsuits against gadolinium MRI contrast dyes spike up across the U.S. The ban which will be in effect till the end of the year 2018, applies to a total of 13 linear agents, including Omniscan, Magnevist, and OptiMark informed South Korea's FDA Minister.

Though gadolinium agents are being used in MRI and MRA procedures in the United States, Canada, Japan, and Switzerland, European health regulators put a halt on the use of gadolinium agents in the brain and spinal MRI scans last year.  

Gadolinium agents MultiHance and OptiMark exposure have been reported to cause brain damages and complications to other organs due to gadolinium retention inside the human body. Lawsuits filed against Linear Gadolinium-Based Contrast Agents (GBCA) claim Gadolinium Deposition Disease (GDD) and Nephrogenic Systemic Fibrosis (NSF) as potential adverse effects.

The U.S. FDA issued a black box warning about NSF for 8 MRI gadolinium agents, applicable to individuals with a pre-existing kidney disorder. Gadolinium multidistrict litigation related to NSF (MDL 1909; In Re: Gadolinium Contrast Dyes Products Liability Litigation) was created in 2008, overlooked by Judge Dan Aaron Polster in the Northern District of Ohio.