News | September 10, 2010

FDA Warns Gadolinium Contrast May Cause Fatal Kidney Condition

September 10, 2010 – The U.S. Food and Drug Administration (FDA) 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). The condition may occur if the drug is administered to certain patients with kidney disease.

Three of the GBCAs – Magnevist (marketed by Bayer Healthcare), Omniscan (GE Healthcare) and Optimark (Covidien) – 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 (MRI) or magnetic resonance angiography (MRA) to help detect abnormalities of organs, blood vessels and other tissues.

NSF involves 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.

Steps Physicians Should Take
To further enhance the safe use of the imaging agents, the FDA recommends that healthcare 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

Lantheus Medical Imaging's gadolinium-based MRA contrast agent Ablavar (gadofosveset trisodium) was not specifically mentioned in the FDA warning. To date, there have been no reported incidents of NSF with the agent. However, Lantheus said the revised language provides clearer guidance to healthcare professionals about the risk of gadolinium-based contrast agent-associated NSF in patients who are renally impaired.  
No substantial changes will be required by the FDA to the Ablavar prescribing information. The agent is a low dose injectable blood pool imaging agent for use to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease (PVD).  It is the first imaging agent with a specific FDA-approved indication for use with MRA. To date, there have been no reported incidents of NSF with Ablavar.

Related Content

Houston Methodist Hospital Enters Multi-Year Technology and Research Agreement With Siemens Healthineers
News | Cardiac Imaging| August 17, 2017
Houston Methodist Hospital and Siemens Healthineers have entered into a multi-year agreement to bring cutting-edge...
ISMRM Issues Guidelines for MRI Gadolinium Contrast Agents
News | Magnetic Resonance Imaging (MRI)| August 15, 2017
The International Society for Magnetic Resonance in Medicine (ISMRM) has provided new guidance in the use of contrast...
GE Healthcare's Signa Premier MRI Receives FDA 510(k) Clearance
Technology | Magnetic Resonance Imaging (MRI)| August 04, 2017
GE Healthcare announced Signa Premier, a new wide bore 3.0T magnetic resonance imaging (MRI) system, is now available...
Cardiac CT scan showing plaque and calcification in the coronary arteries, from a Toshiba CT scanner
News | Business| July 19, 2017
July 19, 2017 — The Society of Cardiovascular Computed Tomography (SCCT) created a reimbursement fee chart for cardia
Guerbet Announces Plans to Streamline Contrast Media Portfolio, gadolinium MRI contrast
News | Contrast Media| July 18, 2017
Guerbet recently announced that it will phase out sales throughout the world of two products: Hexabrix (meglumine and...
ACR Offers Revised Contrast Media in Imaging Manual
News | Contrast Media| July 17, 2017
The American College of Radiology (ACR) recently revised its authoritative guide for the safe and effective use of...
German Workshop Highlights Possibilities of Perfusion MRI
News | Stroke| July 03, 2017
When diagnosing strokes and heart diseases or looking at tumors, perfusion magnetic resonance imaging (MRI) offers a...
Sponsored Content | Videos | Clinical Decision Support| June 29, 2017
Rami Doukky, M.D., system chair, Division of Cardiology, professor of medicine, Cook County Health and Hospitals Syst
Toshiba Medical Introduces Vantage Titan Zen Edition MR
Technology | Magnetic Resonance Imaging (MRI)| June 27, 2017
June 27, 2017 — Toshiba Medical, a Canon Group company, introduced its newest...
Bayer Arterion contrast Injector used to administer medical imaging contrast for CT scans.

Bayer Healthcare's Arterion contrast injector system.

Feature | Contrast Media| June 19, 2017 | Dave Fornell
Here are several updates in medical imaging...
Overlay Init