dismiss

Come visit us at Booth 901 at AHRMM in Washington, DC
Mark your calendars! On August 2nd is our upcoming LIVE Clean Sweep Auction

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 developing miniaturized device to capture brain waves during MR Aiming for a better way to read brain waves

FDA gives approval to neonatal brain MR scanner Features a temperature-controlled incubator that goes directly into the system

Henry Ford Cancer Institute treats first patient with ViewRay's MRIdian Linac 'Takes off the blindfold' for radiation oncologists

fMR imaging reveals how well PTSD patients will respond to therapy Paving the way to more personalized treatment

Stanford Medicine's new virtual reality system assists surgeons and calms patients An immersive trip inside the brain

Researchers develop metal-free MR contrast agent for high-risk patients Will gadolinium become a thing of the past?

Researchers create tumor-targeting MR contrast agent using human proteins May be a viable alternative to gadolinium

Gadolinium retention may be more widespread than previously thought Why that is, remains to be understood

Supplemental breast MR superior to ultrasound for screening breast cancer survivors But what about cost-effectiveness?

German researchers find sweet alternative to conventional MR contrast agents Imaging with glucose using 7T MR scanner

EU group advises suspending market authorization for some gadolinium contrast agents

by Thomas Dworetzky , Contributing Reporter
Four MR contrast agents using gadolinium should have market authorizations stopped in Europe, according to the European Union's committee that weighs the risks of medicine.

The specific agents include:

  • Gadobenic acid, marketed under the trade name MultiHance by Bracco

  • Gadodiamide, sold under the trade name Omniscan by GE Healthcare

  • Gadopentetic acid, marketed as Magnevist by Bayer HealthCare Pharmaceuticals

  • Gadoversetamide, sold as Optimark by Guerbet

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded its “assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorizations,” the group 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



It found evidence of brain deposits of the agent in “small amounts” after MR body scans “but no signs of harm,” it noted.

PRAC called the the evidence of accumulation in the brain “convincing,” based on studies “directly measuring gadolinium in brain tissues and areas of increased signal intensity seen on MR scan images many months after the last injection of a gadolinium contrast agent.'

These recommendations next go to the Committee for Medicinal Products for Human Use (CHMP) for an opinion, which will be released when that body weighs in on the matter.

Despite finding gadolinium in the brain, stated PRAC, “no symptoms or diseases' have been reported associated with the agents," according to the group, which added that long-term side effect data on this issue is “limited.”

In addition, it advised that, “deposition of gadolinium in other organs and tissues has been associated with rare side effects of skin plaques and nephrogenic systemic fibrosis, a scarring condition in patients with kidney impairment. Furthermore, non-clinical laboratory studies have shown that gadolinium can be harmful to tissues.”

The four at issue are all linear agents that have “a structure more likely to release gadolinium,” the group advised.

Macrocyclics are more stable, and the committee has recommended using those instead, “at the lowest does that enhances images sufficiently to make diagnoses, and only when unenhanced body scans are not suitable.”

Not all linear agents would be taken off the shelves. PRAC noted that gadoxetic acid “can remain on the market, as it meets an important diagnostic need in patients with few alternatives. In addition, a formulation of gadopentetic acid injected directly into joints is to remain available because its gadolinium concentration is very low – around 200 times lower than those of intravenous products. Both agents should be used at the lowest dose that enhances images sufficiently to make diagnoses, and only if unenhanced scans are not suitable,” it recommended.
  Pages: 1 - 2 - 3 >>

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 ©2001-2017 DOTmed.com, Inc.
ALL RIGHTS RESERVED