Navigation Links
FDA Approves Gadavist for Central Nervous System Scans
Date:3/15/2011

SILVER SPRING, Md., March 15, 2011 /PRNewswire-USNewswire/ --The U.S. Food and Drug Administration approved Gadavist (gadobutrol), a gadolinium-based contrast agent, for use in patients undergoing magnetic resonance imaging (MRI) of the central nervous system.

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

Gadavist was approved by the FDA on March 14. It provides contrast-enhanced imaging of the central nervous system, helping to detect and visualize lesions that disrupt the cell barrier that normally separates the brain from the blood stream. It also helps to detect and visualize abnormal blood supply and circulation of the central nervous system.

"Gadavist MRI scans improved the visualization of lesions in the central nervous system when compared to MRI scans without contrast," said Libero Marzella, M.D., acting division director, Division of Medical Imaging Products in the FDA's Center for Drug Evaluation and Research.

Gadavist is the sixth gadolinium-based contrast agent (GBCA) for use in patients undergoing magnetic resonance imaging of the central nervous system. It is indicated for adults and children ages 2 years and older. Gadavist is more concentrated than the other GBCAs and should be administered at half the volume. Two clinical studies involving 657 patients and other trial data established the safety and efficacy of Gadavist.

All GBCAs, including Gadavist, carry a boxed warning about the risk of nephrogenic systemic fibrosis (NSF), a rare, but serious, condition associated with the use of GBCAs in certain patients with kidney dysfunction.  NSF is characterized by pain and thickening of the skin, and can cause fibrosis of internal organs. There is no known treatment for NSF. Gadavist is currently considered to be one of the GBCAs with a lower risk of NSF, and is not one of the GBCAs that is contraindicated in patients with acute kidney injury or chronic, severe kidney disease.  

Those receiving Gadavist during the studies reported headache and nausea as the most common adverse reactions. Other adverse events associated with Gadavist included hypersensitivity reactions, involving cardiovascular, respiratory, or skin effects ranging from mild to severe.

Gadavist is manufactured by Bayer Pharmaceuticals, Wayne, N.J.

For more information:

FDA: Questions and Answers on Gadolinium-Based Contrast Agents

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm

Media Inquiries: Amanda Sena, 301-796-0393; amanda.sena@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. U.S. FDA Approves Bayers Gadavist™ (Gadobutrol) Injection for MRI of the Central Nervous System
2. FDA Approves Device to Maintain Blood Flow During Artery Bypass Brain Surgery
3. FDA Approves BENLYSTA® for Lupus in Breakthrough for Millions of Sufferers
4. FDA Approves Revised Alphanate® Labeling to Include Reduced Infectivity of an Experimental Model Agent for vCJD
5. UPDATE: FDA Approves New Drug to Treat Chronic Obstructive Pulmonary Disease
6. FDA Approves New Drug to Treat Chronic Obstructive Pulmonary Disease
7. FDA Approves INTUNIV® (guanfacine) Extended-Release Tablets for Use as Adjunctive Therapy to Stimulants for the Treatment of ADHD in Children and Adolescents
8. FDA Approves Edarbi to Treat High Blood Pressure
9. FDA Approves EDARBI (azilsartan medoxomil) for the Treatment of Hypertension
10. FDA Approves Product to Prevent Bleeding in People With Rare Genetic Defect
11. FDA Approves First 3-D Mammography Imaging System
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... startling report released today, National Safety Council research shows ... plan to eliminate prescription opioid overdoses. Prescription Nation ... the worst drug crisis in recorded U.S. history, assigned a "Making ... , New Mexico , Tennessee ... states, three – Michigan , Missouri ...
(Date:6/23/2016)... Research and Markets has announced the ... report to their offering. ... favourable commercial environment for MedImmune to enter. The US ageing ... serve to drive considerable growth for effective anti-influenza medications. The ... sales considerably, but development is still in its infancy. ...
(Date:6/23/2016)... and BOGOTA, Colombia , June 23, 2016  Astellas today announced the establishment of ... Farma Brasil as the company,s second affiliate in Latin America . ... ... Manager of Astellas Farma Colombia ... ...
Breaking Medicine Technology:
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Marcy was in a crisis. Her son ... lash out at his family verbally and physically. , “When something upset him, he couldn’t ... would use it. He would throw rocks at my other children and say he was ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all areas of ... AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct to ...
(Date:6/24/2016)... , ... June 24, 2016 , ... People across the ... Genome magazine’s Code Talker Award, an essay contest in which patients and their families ... to be presented at the 2016 National Society of Genetic Counselors (NSGC) Annual Education ...
(Date:6/24/2016)... ... June 24, 2016 , ... Puradigm® & Innovative ... has initiated cultivation and processing operations at its production facility, and opened its ... Puradigm is the manufacturer of a complete system of proactive air and surface ...
(Date:6/24/2016)... ... , ... Venture Construction Group (VCG) sponsors Luke’s Wings ... the Woodmont Country Club at 1201 Rockville Pike, Rockville, Maryland, 20852. The event ... that have been wounded in battle and their families. Venture Construction Group is a ...
Breaking Medicine News(10 mins):