Navigation Links
FDA: New Warnings Required on Use of Gadolinium-Based Contrast Agents
Date:9/9/2010

SILVER SPRING, Md., Sept. 9 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration is requiring that gadolinium-based contrast agents (GBCAs) carry new warnings on their labels about the risk of a rare and potentially fatal condition known as nephrogenic systemic fibrosis (NSF), if the drug is administered to certain patients with kidney disease.

(Logo:  http://photos.prnewswire.com/prnh/20090824/FDALOGO)

(Logo:  http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

Three of the GBCAs – Magnevist, Omniscan, and Optimark – will be described as inappropriate for use among patients with acute kidney injury or chronic severe kidney disease. All GBCA labels will emphasize the need to screen patients to detect these types of kidney dysfunction before administration.

GBCAs are intravenous drugs approved by the FDA for use with magnetic resonance imaging or magnetic resonance angiography to help detect abnormalities of body organs, blood vessels, and other tissues.

NSF is a condition involving the formation of excess fibrous connective tissue in the skin, joints, eyes, and internal organs. Symptoms of NSF can include scaling, hardening and tightening of the skin, red or dark patches on the skin, and stiffness. NSF may lead to death, especially if it involves body organs.

The FDA's review of the safety of the most widely used GBCAs determined that Magnevist, Omniscan, and Optimark are associated with a greater risk than other GBCAs for NSF in certain patients with kidney disease. Data suggest that NSF may follow the administration of any GBCA and the FDA continues to assess the safety of each GBCA to better estimate its NSF risks.

"The FDA is requiring these labeling changes to enhance the safe use of gadolinium-based contrast agents, including avoidance of certain agents among patients at highest risk for nephrogenic systemic fibrosis," said Rafel (Dwaine) Rieves, M.D., director of the Division of Medical Imaging Products in the FDA's Center for Drug Evaluation and Research.

To further enhance the safe use of the imaging agents, the FDA recommends that health care professionals:

  • Estimate kidney function through laboratory testing for patients at risk for chronically reduced kidney function
  • Avoid use of GBCAs in patients suspected or known to have impaired drug elimination unless the imaging is essential and not available without contrast
  • Monitor for signs and symptoms of NSF if a GBCA is administered to a patient with acute kidney injury or chronic, severe kidney disease
  • Administer a GBCA only once during an imaging session

Magnevist is marketed by Bayer Healthcare, Omniscan by GE Healthcare, and Optimark by Covidien.

For more information:

Gadolinium Safety Announcement

http://www.fda.gov/Drugs/DrugSafety/ucm223966.htm

Questions and Answers on Gadolinium-Based Contrast Agents

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142889.htm

Media Inquiries: Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Medco Study: Despite FDA Warnings, Nearly One-Third of Asthma Patients Still Treated with Long-Acting Beta Agonists Without Controller Medications, Increasing Their Risk for Complications and Hospitalizations
2. PTCB Certification Required for Pharmacy Technician Employment by Department of Veterans Affairs
3. Should Any Vaccines Be Required for Children? Pros and Cons and Current Research at New ProCon.org Website
4. More Clinical Data Required to Support European Approval of CAP Indication for TYGACIL
5. Miltenyi Biotec Announces Release of Viscover(TM) Preclinical Contrast Agents for in vivo Small Animal Imaging
6. Reportlinker Adds Clinical Laboratory Testing Volume 1: Reagents and Instruments
7. Through 2019, Increased Generic Erosion of Key Agents Such as Lamictal and Depakote/Depakote ER Will Cause a Precipitous $2.3 Billion Decline in the Bipolar Disorder Drug Market
8. Federal Agents Seize FastSize Extenders and FastSize EQM™ Erectile Quality Monitors
9. VisEn Announces New ProSense® 750 FAST and Neutrophil Elastase™ 680 FAST Fluorescence Molecular Imaging Agents at European Molecular Imaging Meeting 2010
10. Epix Pharmaceuticals, Inc. Announces a Change in the May 28, 2010 Auction Sale of Epix Imaging Agents to June 22, 2010
11. New Market Research Report from BioTrends Provides Insight on How Rheumatologists are Utilizing Biologic Agents in the Treatment of Rheumatoid Arthritis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/2/2017)... Oct. 2, 2017 The Rebound mobile app is ... to reverse the tide of prescription drug addiction. The app ... medicine intake and stepping down their dosage in a safe, ... in December 2017; the first 100,000 people to sign up ... http://www.rebound-solution.com/ ...
(Date:9/27/2017)... YORK , Sept. 27, 2017  DarioHealth Corp. (NASDAQ: DRIO), a ... today announced that its MyDario product is expected to appear on The ... when The Dr. Oz Show airs in your area: http://www.doctoroz.com/page/where-watch-dr-oz-show ... The nine-time Emmy award-winning, The Dr. Oz ... The ...
(Date:9/22/2017)... 22, 2017  As the latest Obamacare repeal effort ... Cassidy (R-LA) and Lindsey Graham (R-SC) ... medical device industry is in an odd place.  The ... 2.3% excise tax on medical device sales passed along ... covered patients, increased visits and hospital customers with the ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... ... will be giving viewers the lowdown on sciatica in a new episode of ... that focuses on current events and innovation and investigates each subject in-depth with ...
(Date:10/13/2017)... ... ... “The Journey: From the Mountains to the Mission Field”: the story of a missionary ... Journey: From the Mountains to the Mission Field” is the creation of published author, ... ages and currently teaches a class of ladies at her church, which she has ...
(Date:10/12/2017)... ... 12, 2017 , ... First Healthcare Compliance (FHC), an industry ... a range of technology and learning solutions at the 68th Annual American Healthcare ... be held October 14–18, 2017 at the Mandalay Bay Resort in Las Vegas, ...
(Date:10/12/2017)... ... 2017 , ... Planet Fitness, one of the largest and fastest growing franchisors ... a flagship location in Covington, LA at 401 N. U.S. Highway 190, in January ... Office Depot in the Holiday Square shopping center. Its location allows it to serve ...
(Date:10/12/2017)... ... October 12, 2017 , ... IsoComforter, Inc. ( ... today the introduction of an innovative new design of the shoulder pad. The ... get maximum comfort while controlling your pain while using cold therapy. By utilizing ice ...
Breaking Medicine News(10 mins):