News | Contrast Media | March 13, 2017

European Committee Releases New Recommendations on Gadolinium-based Contrast Agents

Committee recommends suspension of marketing authorization for four linear gadolinium contrast agents that are more likely to leave deposits in the brain following MRI exams

PRAC, European Medicines Agency, gadolinium-based contrast agents, safety recommendations, brain MRI

March 13, 2017 — The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency recently released new recommendations on procedures employing gadolinium-based contrast agents, in which the committee recommended suspension of marketing authorization for four agents.

The EMA initiated a review last March of the risk of gadolinium deposition in brain tissue following the repeated use of gadolinium contrast agents in patients undergoing magnetic resonance imaging (MRI) scans.1 After carrying out an almost year-long, in-depth review of the risk of brain deposits and of the overall safety of these products, the PRAC recommendations2 are as follows:

“EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) has recommended the suspension of the marketing authorizations for four linear gadolinium contrast agents because of evidence that small amounts of the gadolinium they contain are deposited in the brain.

The agents concerned are intravenous injections of gadobenic acid, gadodiamide, gadopentetic acid and gadoversetamide, which are given to patients to enhance images from magnetic resonance imaging (MRI) body scans. (...)

The four agents recommended for suspension are referred to as linear agents. Linear agents have a structure more likely to release gadolinium, which can build up in body tissues.

Other agents, known as macrocyclic agents, are more stable and have a much lower propensity to release gadolinium. The PRAC recommends that macrocyclic agents3 be used at the lowest dose that enhances images sufficiently to make diagnoses and only when unenhanced body scans are not suitable.

Some linear agents will remain available: gadoxetic acid, a linear agent used at a low dose for liver scans, can remain on the market as it meets an important diagnostic need in patients with few alternatives. In addition, a formulation of gadopentetic acid injected directly into joints is to remain available because its gadolinium concentration is very low – around 200 times lower than those of intravenous products. Both agents should be used at the lowest dose that enhances images sufficiently to make diagnoses and only if unenhanced scans are not suitable. (...)”

The recommendations also note that “the companies concerned by this review have the right to request the PRAC to re- examine its recommendations.

The PRAC’s final recommendations will be sent to the Committee for Medicinal Products for Human Use (CHMP) for its opinion. Further details will be published at the time of the CHMP opinion.”

Guerbet, which markets the macrocyclic gadolinium-based contrast agents Dotarem and Artirem, as well as Optimark, a product belonging to the class of linear gadolinium-based contrast agents, voiced its agreement with the PRAC recommendations and said it does not intend to request a re-examination. The company said it is strongly committed to providing healthcare professionals with a comprehensive range of effective and safe contrast media in order to improve diagnosis, prognosis and quality of life for patients.

Watch the ITNtv video “MRI Gadolinium Contrast Retention in the Brain.”

Read the ITN feature story “Gadolinium May Remain in Brain After Contrast MRI.”

For more information: www.ema.europa.eu

References

1. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Gadolinium- containing_contrast_agents/human_referral_prac_000056.jsp&mid=WC0b01ac05805c516f
2. Gadolinium Article-31 referral - PRAC concludes assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorisations. 10/03/2017

Related Content

Turkish Hospital Begins MR-Guided Radiation Therapy With Viewray MRIdian Linac
News | Image Guided Radiation Therapy (IGRT) | September 21, 2018
ViewRay Inc. announced that Acibadem Maslak Hospital in Istanbul, Turkey has begun treating patients with ViewRay's...
Machine Learning IDs Markers to Help Predict Alzheimer's

Neurologists use structural and diffusion magnetic resonance imaging (MRI) to identify changes in brain tissue (both gray and white matter) that are characteristic of Alzheimer's disease and other forms of dementia. The MRI images are analyzed using morphometry and tractography techniques, which detect changes in the shape and dimensions of the brain and in the tissue microstructure, respectively. In this example, the images show the normal brain of an elderly patient. Image courtesy of Jiook Cha.

News | Neuro Imaging | September 20, 2018
New research has shown a combination of two different modes of magnetic resonance imaging (MRI), computer-based...
Ingenia Ambition X 1.5T MR. This innovation is the latest advance in the Ingenia MRI portfolio, which comprises fully-digital MRI systems, healthcare informatics and a range of maintenance and life cycle services for integrated solutions that empower a faster, smarter, and simpler path to enabling a confident diagnosis
News | Magnetic Resonance Imaging (MRI) | September 14, 2018
Philips, a global leader in health technology, launched the Ingenia Ambition X 1.5T MR.
Gadolinium contrast agents (GBCAs) are partly retained in the brain, raising safety concerns, as seen in this MRI.

Gadolinium contrast agents (GBCAs) are partly retained in the brain, raising safety concerns, as seen in this MRI.

News | Contrast Media | September 12, 2018
In February 2018, a workshop was held at the National Institutes of Health (NIH) in Bethesda, Maryland, to explore co
Veye Chest version 2
News | Lung Cancer | September 11, 2018
Aidence, an Amsterdam-based medical AI company, announced that Veye Chest version 2, a class IIa medical device, has
Sponsored Content | Case Study | Magnetic Resonance Imaging (MRI) | September 07, 2018 | By Sabine Sartoretti, M.D.
As soon as the Compressed SENSE technology became available to the MRI team at Kantonsspital Winterthur (Switzerland),...

Image courtesy of Philips Healthcare

Feature | Magnetic Resonance Imaging (MRI) | September 06, 2018 | By Melinda Taschetta-Millane
According to the Prescient & Strategic Intelligence report, “Global Magnetic Resonance Imaging (MRI) Market Size,...
Brain Iron Levels May Predict Multiple Sclerosis Disabilities
News | Neuro Imaging | August 31, 2018
A new, highly accurate magnetic resonance imaging (MRI) technique can monitor iron levels in the brains of multiple...
Study Finds Multiple Sclerosis Drug Slows Brain Shrinkage

An NIH-funded clinical trial suggested that the anti-inflammatory drug ibudilast may slow brain shrinkage caused by progressive MS. Image courtesy of Robert J. Fox, M.D., Cleveland Clinic.

News | Neuro Imaging | August 30, 2018
August 30, 2018 — Results from a clinical...
Rapid Cardiac MRI Technique May Cut Costs, Boost Care in Developing World
News | Magnetic Resonance Imaging (MRI) | August 29, 2018
A newly developed rapid imaging protocol quickly and cheaply diagnosed heart ailments in patients in Peru, according to...