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FDA investigating risk of gadolinium contrast agent brain deposits

(13.08.2015)


Background:
Gadolinium-based contrast agents are used to increase the visibility of internal body structures in MRI scans. MRI contrast agents may be administered by injection or orally. While oral administration is well suited to gastrointestinal tract (GI) scans, intravascular administration proves more useful for most other scans. Today, more than 10 million GBCA injections are performed annually for purposes of medical imaging. Gadolinium, which is cytotoxic in humans, could be safely administered to patients intravenously when bonded with an organic ligand, which surrounds the gadolinium and acts as a chaperone to escort it into—and out of—the body


Effect of contrast agent on images: Defect of the
blood–brain barrier after stroke shown in MRI.
T1-weighted images, left image without, right image
with contrast medium administration.

In patient with normal kidney function GBCAs are mostly eliminated from the body through the kidneys within few hours, but trace amounts of gadolinium may stay in the body long-term, according to the FDA. Since the safety of GBCAs is partially based on the fact that their residence time in the body is very short, researchers advise that GBCAs should not be given to any individual with chronic kidney disease.


New studies:
Recent studies suggest that gadolinium-based contrast agent (GBCA) may stay in the brains of patients, even if these have normal kidney function.

According to FDA, it is unknown whether these deposits cause adverse effects. FDA’s National Center for Toxicological Research (NCTR) will further investigate safety risks in consultation with researchers and industry, the statement said. Based on the information available at this time, the FDA is not requiring manufacturers to make changes to the labels of GBCA products. The agency is, however, recommending that clinicians limit GBCA use to situations in which the additional information provided by the contrast is necessary for patient care.

“Health care professionals are also urged to reassess the necessity of repetitive GBCA MRIs in established treatment protocols,” the FDA said.

The FDA encourages health care professionals and patients to report side effects and adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: www.fda.gov/MedWatch/report



Related information:

FDA: Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - FDA Evaluating the Risk of Brain Deposits With Repeated Use



Related studies:

Emanuel Kanal, Michael F. Tweedle, Residual or Retained Gadolinium: Practical Implications for Radiologists and Our Patients, Radiology, 275/3 (2015) 630-634. DOI: 10.1148/radiol.2015150805

Robert J. McDonald, Jennifer S. McDonald, David F. Kallmes, Mark E. Jentoft, David L. Murray, Kent R. Thielen, Eric E. Williamson, Laurence J. Eckel,  Intracranial Gadolinium Deposition after Contrast-enhanced MR Imaging, Radiology, 275/3 (2015) 772-782. doi: 10.1148/radiol.15150025

Alexander Radbruch, Lukas D. Weberling, Pascal J. Kieslich, Oliver Eidel, Sina Burth, Philipp Kickingereder, Sabine Heiland, Wolfgang Wick, Heinz-Peter Schlemmer, Martin Bendszus, Gadolinium Retention in the Dentate Nucleus and Globus Pallidus Is Dependent on the Class of Contrast Agent, Radiology, 275/3 (2015) 783-791. DOI: 10.1148/radiol.2015150337

Tomonori Kanda, Marie Osawa, Hiroshi Oba, Keiko Toyoda, Jun’ichi Kotoku,  Takahiro Haruyama, Koji Takeshita, Shigeru Furui, High Signal Intensity in Dentate Nucleus on Unenhanced T1-weighted MR Images: Association with Linear versus Macrocyclic Gadolinium Chelate Administration, Radiology, 275/3 (2015) 803-809. DOI: 10.1148/radiol.14140364

Tomonori Kanda, Toshio Fukusato, Megumi Matsuda, Keiko Toyoda, Hiroshi Oba, Jun’ichi Kotoku, Takahiro Haruyama, Kazuhiro Kitajima, Shigeru Furui, Gadolinium-based Contrast Agent Accumulates in the Brain Even in Subjects without Severe Renal Dysfunction: Evaluation of Autopsy Brain Specimens with Inductively Coupled Plasma Mass Spectroscopy, Radiology, 276/1 (2015) 228-232. DOI: 10.1148/radiol.2015142690




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last time modified: November 29, 2015



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