dismiss

This Thursday, Jan 25th is our next Clean Sweep Live Auction: Click to view the full catalogue and pre-bid now

DOTmed Home MRI Oncology Ultrasound Molecular Imaging X-Ray Cardiology Health IT Business Affairs
News Home Parts & Service Operating Room CT Women's Health Proton Therapy Endoscopy HTMs Mobile Imaging
SEARCH
Current Location:
>
> This Story


Log in or Register to rate this News Story
Forward Printable StoryPrint Comment

 

 

MRI Homepage

Researchers develop PET tracer that can measure damage caused by MS Offers advantages not found with conventional MR

Engineering solution reduces MR production and scanning costs Could cut cost of MR analysis in half

CMS may reimburse MR with cardiac implants beyond 'MR-friendly' Shift attributed to mounting evidence of scan safety

FDA gives nod to MR-conditional labeling for Abbott ICD and CRT-D Labeling will reduce anxiety for patients who need scanning

New technique may pave way toward much lower-cost MR technology Eliminates need for superconducting magnets

Asia-Pacific imaging market to grow at a CAGR of 10 percent through 2021 Technological advancement is one of the main drivers

MR replaces biopsy in kidney cancer assessment Involves multiparametric MR protocols

The five biggest MR stories of 2017 Ultrahigh-powered magnets, a new gold standard in radiotherapy and the Chuck Norris effect on gadolinium

Older pacemakers still safe in MR New findings suggest CMS should change policy to cover these scans

Anatomage launches Anatomage Cloud for medical image sharing Response to rising number of specialists using cone beam CT imaging

FDA to require gadolinium retention label warnings

by Thomas Dworetzky , Contributing Reporter
In the ongoing discussion over gadolinium-based contrast agents, the U.S. Food and Drug Administration (FDA) has now issued a safety communication.

It will require “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,” the agency said in a statement.

Story Continues Below Advertisement

The (#1 Resource) for Medical Imaging and Peripherals. Call 1-949-273-8000

As a Master Distributor for major brands Barco, Philips, and Sony, we offer custom imaging solutions. With our renowned OEM Solutions and Service/Repair Center, Ampronix is a one-stop shop for HD Medical LCD Displays--Printers--Recorders--4K Cameras



No direct link to adverse health impacts have been found in those with normally functioning kidneys, noted the agency, explaining that “we have concluded that the benefit of all approved GBCAs continues to outweigh any potential risks.”

That said, the added review and talks with the Medical Imaging Drugs Advisory Committee, has led to changes designed to highlight retention issues with MR imaging using GBCA.

These include a new Medication Guide for patients to be read prior to getting a GBCA, as well as requiring makers to perform further animal and human studies over its safety.

The kidneys usually clear the agents, but trace amounts have been found in the body. For those with a higher risk of retention, such as patients who may need multiple doses, those who are pregnant, children and those with inflammatory conditions, the agency advises care, but stressed, “do not avoid or defer necessary GBCA MR scans.”

For those at risk, the FDA pointed out that linear GBCAs “result in more retention and retention for a longer time than macrocyclic GBCAs,” and to give them accordingly.

As a result of its review, stated Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, “we recommend that health care professionals consider the retention characteristics of each agent when choosing a GBCA for patients who may be at higher risk, such as those who may require repeat GBCA MR scans to monitor a chronic condition."

In specific, it stated that body levels of gadolinium are highest with Omniscan (gadodiamide) or OptiMARK (gadoversetamide) compared with Eovist (gadoxetate disodium), Magnevist (gadopentetate dimeglumine), or MultiHance (gadobenate dimeglumine). Gadolinium levels are lowest when using Dotarem (gadoterate meglumine), Gadavist (gadobutrol), and ProHance (gadoteridol) – and levels are similar for these agents.

Although the health impact of gadolinium retention has yet to be established, the agency noted that “we are continuing to assess the health effects of gadolinium retention in the body and will update the public when new information becomes available.”
  Pages: 1 - 2 >>

MRI Homepage


You Must Be Logged In To Post A Comment

Advertise
Increase Your
Brand Awareness
Auctions + Private Sales
Get The
Best Price
Buy Equipment/Parts
Find The
Lowest Price
Daily News
Read The
Latest News
Directory
Browse All
DOTmed Users
Ethics on DOTmed
View Our
Ethics Program
Gold Parts Vendor Program
Receive PH
Requests
Gold Service Dealer Program
Receive RFP/PS
Requests
Healthcare Providers
See all
HCP Tools
Jobs/Training
Find/Fill
A Job
Parts Hunter +EasyPay
Get Parts
Quotes
Recently Certified
View Recently
Certified Users
Recently Rated
View Recently
Certified Users
Rental Central
Rent Equipment
For Less
Sell Equipment/Parts
Get The
Most Money
Service Technicians Forum
Find Help
And Advice
Simple RFP
Get Equipment
Quotes
Virtual Trade Show
Find Service
For Equipment
Access and use of this site is subject to the terms and conditions of our LEGAL NOTICE & PRIVACY NOTICE
Property of and Proprietary to DOTmed.com, Inc. Copyright ©2001-2018 DOTmed.com, Inc.
ALL RIGHTS RESERVED