FDA Approved Magnevist Alleged For Multiple Organ Damages

FDA Approved Magnevist Alleged For Multiple Organ Damages

Introduction

The U.K. Royal College of Radiologists recently updated a 23-page document, which contains the risks linked to the use of gadolinium-based MRI contrast dyes, along with guidance that covers safety, prescribing, consent, identification of patients at increased risk from contrast administration, pregnancy and lactation. Magnevist is one of the eight approved gadolinium-based MRI contrast dyes for use in the United States by the U.S. Food & Drug Administration (FDA).

According to a case filed the U.S. District Court for the Eastern District of Louisiana on April 26, a couple alleged that the dye Magnevist injected before undergoing an MRI scan caused a number of symptoms like confusion, weakness, fatigue, difficult and painful movement, which are commonly referred to as Gadolinium Deposition Disease. The husband also indicated that Gadolinium was deposited in his brain, heart, liver, and kidney.

Dozens of lawsuits are filed in the United States for Gadolinium Deposition Disease alleging the side effects of Magnevist, a gadolinium-based contrast agent (GBCA) used to enhance MRI scans. The plaintiffs claimed that their kidneys were healthy when they underwent MRIs and stated the manufacturers failed to appropriate safety warnings. The manufacturers were required to provide warnings in a Medication Guide, which all patients receiving an MRI contrast dye will be asked to read after the drug safety communication was issued by the FDA In December 2017. The number of Gadolinium retention lawsuits are expected to continue to increase over the coming months and years.