![]() Intra-articular formulations of the linear agent gadopentetic acid will continue to be available because the dose of gadolinium that is required for these scans is very low.Two intravenous linear agents – gadoxetic acid and gadobenic acid – remain available as these agents undergo hepatic uptake, and can be used for imaging poorly vascularised hepatic lesions, especially in delayed phase imaging, that cannot be adequately studied with other agents.The marketing authorisations for the intravenous linear agents gadodiamide and gadoversetamide, as well as the intravenous formulation of the linear agent gadopentetic acid, are now suspended in the EU.No adverse neurological effects, such as cognitive or movement disorders, have been attributed to gadolinium deposition in the brain with any gadolinium agents.Data on stability, as well as in vitro and non-clinical studies, show that linear gadolinium agents release gadolinium from the ligand molecules to a greater extent than macrocyclic agents.Gadolinium deposition in the brain has been confirmed by mass spectrometry and increases in signal intensity in brain tissue.The final recommendations have been sent to the European Commission, which issued a final legally binding decision applicable in all EU Member States. The suspensions or restrictions on linear agents can be lifted if the companies concerned provide evidence of new benefits in an identified patient group that outweigh the risk of brain deposition or if the companies can modify their products so they do not release gadolinium significantly or cause its retention in tissues.ĮMA's scientific review of gadolinium deposition in brain and other tissues is now concluded. These products 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. In addition, gadopentetic acid given intra-articularly (into the joint) can continue to be used for joint scans because the dose of gadolinium used for joint injections is very low.Īll other intravenous linear products (gadodiamide, gadopentetic acid and gadoversetamide) should be suspended in the EU.Īnother class of gadolinium agents known as macrocyclic agents (gadobutrol, gadoteric acid and gadoteridol) are more stable and have a lower propensity to release gadolinium than linear agents. The intravenous linear agents gadoxetic acid and gadobenic acid can continue to be used for liver scans because they are taken up in the liver and meet an important diagnostic need. There is currently no evidence that gadolinium deposition in the brain has caused any harm to patients however EMA has recommended restrictions and suspensions for some intravenous linear agents in order to prevent any risks that could potentially be associated with gadolinium brain deposition. The recommendations – confirmed by EMA's Committee for Medicinal Products for Human Use ( CHMP) – followed a review that found that gadolinium deposition occurs in brain tissues following use of gadolinium contrast agents. ![]() To restrict the use of some linear gadolinium agents used in MRI body scans and to suspend the authorisations of others. On 20 July 2017, the European Medicines Agency (EMA) concluded its review of gadolinium contrast agents, Recommendations conclude EMA's scientific review of gadolinium deposition in brain and other tissues EMA's final opinion confirms restrictions on use of linear gadolinium agents in body scans ![]()
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