News | Magnetic Resonance Imaging (MRI) | July 12, 2016

ACR Manual on Contrast Media Addresses FDA Gadolinium Safety Concerns

Updated resource for radiologists guides safe, effective use of contrast media in daily practice

gadolinium, ACR Manual on Contrast Media, update, FDA safety concerns

July 12, 2016 — The updated American College of Radiology (ACR) Manual on Contrast Media contains a statement addressing the U.S. Food and Drug Administration (FDA) safety communication on use of gadolinium-based contrast agents for magnetic resonance imaging (MRI).

Gadolinium-based contrast agents are administered to approximately 30 million patients every year to improve the diagnostic accuracy of MR examinations. Researchers have found that gadolinium-based contrast agents may leave deposits in the brain, bone and other organs. “If the decision is made to use a gadolinium-based contrast agent for an MRI study for an individual patient, multiple factors need to be considered … including diagnostic efficacy, relaxivity, rate of adverse reactions, dosing/concentration and propensity to deposit in more sensitive organs, such as the brain,” notes a joint statement from the ACR and the American Society of Neuroradiology (ASNR).

“This vital guide for radiologists enhances the safe and effective use of contrast media in daily practice to ensure optimal patient care,” said Jacqueline Bello, M.D., FACR, chair of the ACR Commission on Quality and Safety. “The timely inclusion of the ACR and ASNR joint statement addresses questions posed by many radiology professionals about gadolinium-based contrast agents in the previous months,” she added.

“Reviews from radiologists show that this reference on contrast media is a practical and valuable resource in support of the millions of radiological examinations that may be assisted by intravascular contrast media annually,” said James H. Ellis, M.D., FACR, chair of the ACR Committee on Drugs and Contrast Media. He noted that the manual continues to be available for free as a frequently updated downloadable document on the ACR website.

Version 10.2 of the resource for using contrast media in diagnostic imaging includes:

  • An updated footnote in “Metformin,” concerning the FDA’s April 2016 guidance on patients who take this medication and who receive iodinated contrast media;
  • Information and new references about intra-osseous injection in “Injection of Contrast Media”; and
  • The addition of a document version history, so users may track changes from version to version.

For more information:

Related Content

Ligand Establishes Program to Develop Captisol-Enabled, Next-Generation Diagnostic Imaging Contrast Agents
News | Contrast Media | January 19, 2018
Ligand Pharmaceuticals Inc. announced initiation of a program to develop contrast agents with reduced renal toxicity....
FDA Holds MIDAC Meeting on Gadolinium-Based Contrast Agents. Image by Marilyn Fornell
News | Contrast Media | September 07, 2017
The U.S. Food and Drug Administration (FDA) announced it would hold a meeting of the Medical Imaging Drugs Advisory...
European Medicines Agency Issues Update on Gadolinium Contrast Agents
News | Contrast Media | August 29, 2017
August 29, 2017 — The European Medicines Agency (EMA) issued a final opinion that recommended restricting the use of
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...
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...
PRAC, European Medicines Agency, gadolinium-based contrast agents, safety recommendations, brain MRI
News | Contrast Media | March 13, 2017
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency recently released new...
Lantheus Medical Imaging, Definity, FDA approval, label update, echocardiography, cardiac shunt contraindication
Technology | Contrast Media | February 02, 2017
Lantheus Medical Imaging Inc. announced U.S. Food and Drug Administration (FDA) approval of a label update for Definity...
CT, computed tomography, IV contrast media, acute kidney injury risk, Annals of Emergency Medicine study

A new study in Annals of Emergency Medicine finds no association between intravenous contrast media used in computed tomography (CT) and kidney damage. Roughly 80 million doses of IV contrast media are given every year. Credit: American College of Emergency Physicians

News | Contrast Media | January 30, 2017
Intravenous contrast media (typically iohexol or iodixanol) used in computed tomography (CT) does not appear to be...
GE Healthcare, Optison ultrasound contrast agent, FDA labeling change, cardiac shunts, intra-arterial injection
Technology | Contrast Media | October 04, 2016
GE Healthcare announced that the U.S. Food and Drug Administration (FDA) has approved a label change for the ultrasound...
Overlay Init