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 ce
'/>"/>

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

Page: 1 2

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:8/28/2015)... PUNE, India , August 28, 2015 ... "Cancer Biomarker Market by Tumor (Breast, Lung, Prostate) Type ... Immunoassay) Application (Diagnostic, Drug Discovery, Prognostic) & Geography - ... Biomarkers Market is expected to reach around 17,689.0 Million ... the forecast period of 2015 to 2020. ...
(Date:8/28/2015)... , Aug. 28, 2015  Today, in final ... (CDC) Contact Lens Health Week, 1-800 Contacts is sharing ... found that contact lens wearers who do not properly ... risk for eye infections. Most contact ... lenses, but a clean lens case is sometimes overlooked.  ...
(Date:8/28/2015)... -- Research and Markets ( http://www.researchandmarkets.com/research/sqh7xc/investigation ... Report on China,s Ranibizumab Market, 2012-2019" report to ... approved by CFDA to treat wet age- related macular ... of Novartis, is available in the Chinese market. However, ... for the treatment of wet AMD in ...
Breaking Medicine Technology:Cancer Biomarkers Market Worth 17,689.0 Million USD by 2020 2Cancer Biomarkers Market Worth 17,689.0 Million USD by 2020 3Cancer Biomarkers Market Worth 17,689.0 Million USD by 2020 4Cancer Biomarkers Market Worth 17,689.0 Million USD by 2020 51-800 Contacts Shares Tips on How to Clean Lens Cases 2Investigation Report on China's Ranibizumab Market, 2012-2019 2
... Oct. 12, 2011 Endo Pharmaceuticals (Nasdaq: ENDP ... October 27, 2011 and will host a conference call and ... results.   David P. Holveck, president and CEO ... executive vice president of R&D, Alan Levin, executive vice president ...
... the results of a recent statewide survey, more than half ... their (parents,) prescription (Rx) medications, and one in seven parents ... not prescribed for their child. The survey was ... during a briefing at the Massachusetts State House hosted by ...
Cached Medicine Technology:Endo Pharmaceuticals to Announce Third Quarter 2011 Financial Results on October 27, 2011 2More Than Half of Massachusetts Parents Say Their Kids Have Access to Abusable Prescription Drugs in Their Homes 2More Than Half of Massachusetts Parents Say Their Kids Have Access to Abusable Prescription Drugs in Their Homes 3More Than Half of Massachusetts Parents Say Their Kids Have Access to Abusable Prescription Drugs in Their Homes 4
(Date:8/30/2015)... ... August 30, 2015 , ... InHealth Media ( http://www.inhealthmedia.com ) ... Communications Director for InHealth Media. Mr. Spector comes with a wide array ... doing on-air television, producing shows, on air-radio and media relations. , Brian ...
(Date:8/30/2015)... Boca Raton, Fl (PRWEB) , ... August 30, ... ... today that Kathleen Kall has been promoted from Administrative assistant to Executive Assistant ... communication, you’ll interact with a proven professional, focused on your goals. Kathleen ...
(Date:8/29/2015)... ... August 30, 2015 , ... ... — 1:30 p.m. – 3:00 p.m. EDT, http://www.fdanews.com/electronicinformedconsent , The simple ... digital handwritten signature. , Clinical trial sites can now use audio, ...
(Date:8/29/2015)... ... August 29, 2015 , ... Targeted therapies, made ... the lives of patients, according to a newly published report. Surviving Mesothelioma has ... full article. , The authors of the new paper focus on several ...
(Date:8/29/2015)... ... 29, 2015 , ... ProDrop Particles includes over 40 particle backdrops designed for ... unique footage that users can shrink and stretch in the Final Cut Pro X ... customize color, brightness, scale, speed, range, and flare attributes with intuitive controls found in ...
Breaking Medicine News(10 mins):Health News:InHealth Media Appoints New Global Communications Director 2Health News:NPI Appoints New Executive Assistant To CEO 2Health News:FDAnews Announces — Electronic Informed Consent for Clinical Trials: Best Practices Webinar, Sept. 15, 2015 2Health News:FDAnews Announces — Electronic Informed Consent for Clinical Trials: Best Practices Webinar, Sept. 15, 2015 3Health News:FDAnews Announces — Electronic Informed Consent for Clinical Trials: Best Practices Webinar, Sept. 15, 2015 4Health News:Top Mesothelioma Researchers Highlight Targeted Therapies in New Report, According to Surviving Mesothelioma 2Health News:FCPX Effects Developer, Pixel Film Studios, Releases ProDrop Particles. 2
... By Amanda Gardner HealthDay Reporter , THURSDAY, ... the American Southwest, experts are worried not just about ... risks both to nearby residents and to those living ... are anecdotal, people on the front lines of health ...
... use, encouraging infants and young children in preschool and ... play, and requiring child care providers to promote healthy ... curb high rates of obesity among America,s youngest children, ... The report recommends steps that should ...
... (HealthDay News) -- Strategies to encourage physical activity, healthy eating ... of obesity among infants, toddlers and preschoolers in the United ... Limiting children,s TV time is a key recommendation. ... 2 to 5 have doubled since the 1980s. About 10 ...
... 2011 A new automated sample preparation system ... platform has been developed for proteomic biomarker discovery ... Research Institute (TGen) and the Biodesign Institute at ... integrated, high-throughput system is a key tool in ...
... , THURSDAY, June 23 (HealthDay News) -- Minimally invasive ... the deep veins compared with traditional surgery, University of ... called venous thromboembolism (VTE), occur in about a quarter ... The benefits of less invasive laparoscopic surgery also include ...
... investigating how to help deaf people, who have received ... Music professor David Nicholls and Dr Rachel van ... Research (ISVR) have secured a 109,000 grant from the ... from the South of England Cochlear Implant Centre, based ...
Cached Medicine News:Health News:Smoke From Wildfires in Southwest May Be Health Hazard 2Health News:Smoke From Wildfires in Southwest May Be Health Hazard 3Health News:Policies that promote healthy eating, activity and sleep are needed to curb obesity in infants, toddlers and preschoolers 2Health News:Policies that promote healthy eating, activity and sleep are needed to curb obesity in infants, toddlers and preschoolers 3Health News:Policies that promote healthy eating, activity and sleep are needed to curb obesity in infants, toddlers and preschoolers 4Health News:Ways to Curb Childhood Obesity Outlined in U.S. Report 2Health News:Less Invasive Colon Surgery Results in Fewer Blood Clots: Study 2Health News:Helping deaf people to enjoy music again 2
The 7700 Reciprocating Saw completes the large power system with our simple twist-lock blade hub and selection of saw blades....
... 7600 Oscillating Saw offers unparalleled ... thanks to its 14.4V NiMH ... head may be rotated into ... any plane and will accept ...
... of a pistol-grip handpiece available in Pneumatic, ... range of couplers that can be used ... ,MicroAire SmartDriver. Modular Pistol-Grip instrument used ... module for drilling, pinning, cutting, and debridement. ...
... The SmartDriver System consists of a ... Battery Power, with a wide range of ... variety of orthopedic surgical applications., ,The ... and speed compared to the original Battery ...
Medicine Products: