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Regulatory News | 21 July 2017 | By Michael Mezher
The European Medicines Agency (EMA) on Friday said it plans to suspend the marketing authorization for three gadolinium contrast agents and restrict the use of others after a review by the agency's Pharmacovigilance Risk Assessment Committee (PRAC) confirmed evidence of gadolinium accumulation in patients' brains months after being injected.
EMA says the move is a precautionary measure, as there is currently no evidence that gadolinium accumulation in the brain poses a health risk to patients.
The US Food and Drug Administration (FDA) is also currently reviewing the safety of gadolinium contrast agents, but as of May 2017 the agency says it has not identified any adverse effects of gadolinium retention in the brain and that restricting their use "is not warranted at this time."
Specifically, EMA says it plans to suspend the authorizations of three intravenous linear gadolinium contrast agents, Magnevist (gadopentetic acid), Omniscan (gadodiamide) and Optimark (gadoversetamide).
Two other intravenous linear products—Primovist (gadoxeticacid) and Multihance (gadobenic acid)—will continue to be available, as EMA says they "can be used for imaging poorly vascularized hepatic lesions, especially in delayed phase imaging, that cannot be adequately suited with other agents."
EMA is also recommending restricting the use of the intra-articular form of Magnevist, which the agency says "can continue to be used for joint scans because the dose of gadolinium used for joint injections is very low."
Additionally, EMA says that macrocyclic gadolinium contrast agents "can continue to be used in their current indications but in the lowest doses that enhance images sufficiently and only when unenhanced body scans are not suitable."
With the conclusion of EMA's review, the recommendations will now be forwarded to the European Commission, which will issue a legally binding decision on the agency's recommendations.