Navigation Links
FDA: New Warnings Required on Use of Gadolinium-Based Contrast Agents

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.



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

Questions and Answers on Gadolinium-Based Contrast Agents

Media Inquiries: Karen Riley, 301-796-4674;

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 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:
(Date:6/26/2016)... , June 27, 2016  VMS Rehab Systems, ... Board will take whatever measures required to build a ... stock which is currently listed on the OTC Markets-pink ... Company Chairman and CEO, "We are seeing an anomaly ... to understand, not only by the Company, but shareholders ...
(Date:6/24/2016)... SAN FRANCISCO, Calif. , June 24, 2016 ... GBT ), a biopharmaceutical company developing novel therapeutics ... significant unmet needs, today announced the closing of ... shares of common stock, at the public offering ... shares in the offering were offered by GBT. ...
(Date:6/24/2016)... , June 24, 2016 The Academy ... of recommendations that would allow biopharmaceutical companies ... with entities that make formulary and coverage decisions, a ... "value" of new medicines. The recommendations address ... not appear on the drug label, a prohibition that ...
Breaking Medicine Technology:
(Date:6/27/2016)... , ... June 27, 2016 , ... recently awarded ... Eyeglasses . , Millions of individuals in the United States and Canada wear ... a way to both correct vision and make a fashion statement. Even celebrities use ...
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... PawPaws ... a new product that was developed to enhance the health of felines. The formula ... , The two main herbs in the PawPaws Cat Kidney Support Supplement ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery services, can ... Surgery and to Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey ... cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, Dr. Omkar ... M.D from the David Geffen School of Medicine at UCLA. He trained in Internal ... complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had ...
(Date:6/24/2016)... Los Angeles, CA (PRWEB) , ... June 24, 2016 , ... ... plastic surgery procedures that most people are unfamiliar with. The article goes on to ... known procedures, but also many of these less common operations such as calf and ...
Breaking Medicine News(10 mins):