EMA Launches Investigation Into Gadolinium Deposits in Brain

Pauline Anderson

March 18, 2016

The European Medicines Agency (EMA) is launching a review of the risk of gadolinium deposition in brain tissue of patients undergoing MRI that uses gadolinium-based contrast agents (GBCAs).

These contrast agents may be given to patients before or during MRI to help doctors obtain better images of organs and tissues. After administration, they are mostly eliminated via the kidneys, but emerging research indicates that deposits can build up in some body tissues, including in the liver, kidney, muscle, skin and bone, and now there's growing concern about the brain.

Recently, several publications have reported that gadolinium contrast agents accumulate in brain tissue.

Earlier this year, EMA's Pharmacovigilance Risk Assessment Committee (PRAC) reviewed these publications. Although no adverse effects relating to gadolinium brain deposition have been reported to date, PRAC will review in-depth the risk for brain deposits and the overall safety of these products, according to an EMA press statement released today.

The PRAC's recommendations will be sent to the Committee for Medicinal Products for Human Use, which will issue the Agency's final opinion.

FDA Investigation

The announcement by EMA follows a similar investigation launched last summer by the US Food and Drug Administration (FDA), reported at that time by Medscape Medical News. In July 2015, the FDA announced an investigation into the risk of brain deposits following repeated use of GBCAs for MRI.

The FDA press release noted that evidence suggest that deposits of GBCAs remain in the brains of some patients who undergo four or more contrast MRI scans, long after the last administration.

In one study, published last year in Radiology, researchers at the Mayo Clinic found deposits of gadolinium in the brains of deceased patients who had undergone multiple contrast-enhanced MRI examinations during their lifetime. The analysis showed a dose-dependent relationship between use of GBCAs and deposition of gadolinium in neural tissues.

That study was prompted by a previous study from Japan that noted a progressive increase in signal in certain parts of the brain after administration of successive doses of gadolinium.

To reduce the potential for gadolinium accumulation, the FDA suggested that healthcare professionals consider limiting GBCA use to clinical circumstances in which the additional information provided by the contrast is necessary and to reassess the necessity of repetitive GBCA MRIs in established treatment protocols. 

GBCAs contain the rare earth metal gadolinium and an organic ligand. Approved by the FDA in 1988, they are now the most commonly used MRI contrast agents. A previous EMA review of gadolinium contrast agents in 2010 evaluated the risk for nephrogenic systemic fibrosis.

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