New Class Warnings for MRI Contrast Agents

Gadolinium-based Contrast Agents (GBCAs): Drug Safety Communication – Retained in Body; New Class Warnings

The FDA is requiring new warnings about the risks of undergoing an MRI in which a contrast agent containing gadolinium is used. Gadolinium is a metal and studies show that it can be retained in brain tissue for years after the MRI. In addition, in patients with pre-existing kidney disease, the use of gadolinium based contrast agents may further damage the kidneys. Anyone undergoing an MRI in which contrast agent is to be used should speak with their doctor about the risks of using gadolinium based contrast agents.

AUDIENCE: Radiology, Health Care Professional, Patient

ISSUE: FDA is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) concerning gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs. Gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function, and FDA has concluded that the benefit of all approved GBCAs continues to outweigh any potential risks.

GBCAs are used with medical imaging devices called MRI scanners to examine the body for problems such as cancer, infections, or bleeding. GBCAs contain gadolinium, a heavy metal. These contrast agents are injected into a vein to improve visualization of internal organs, blood vessels, and tissues during an MRI, which helps health care professionals diagnose medical conditions. After being administered, GBCAs are mostly eliminated from the body through the kidneys. However, trace amounts of gadolinium may stay in the body long-term. Many GBCAs have been on the market for more than a decade.

There are two types of GBCAs based on their chemical structures: linear and macrocyclic.  Linear GBCAs result in more retention and retention for a longer time than macrocyclic GBCAs. Gadolinium levels remaining in the body are higher after administration of Omniscan (gadodiamide) or OptiMARK (gadoversetamide) than after Eovist (gadoxetate disodium), Magnevist (gadopentetate dimeglumine), or MultiHance (gadobenate dimeglumine). Gadolinium levels in the body are lowest after administration of Dotarem (gadoterate meglumine), Gadavist (gadobutrol), and ProHance (gadoteridol); the gadolinium levels are also similar across these agents.

Read the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm589580.htm

 

By |2018-02-14T15:21:51+00:00December 20th, 2017|Attorney Articles, Medical Recalls|Comments Off on New Class Warnings for MRI Contrast Agents