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EMA Issues Final Opinion Limiting Gadolinium Contrast Agents in Body Scans

July 28, 2017

The European Medicines Agency issued a final opinion confirming restrictions on the use of certain gadolinium agents in MRI body scanners and suspending the authorizations of others.

The agency conducted a scientific review to investigate reports of gadolinium residues in brain and other tissues following the use of gadolinium contrast agents in MRI procedures.

The intravenous linear products gadodiamide, gadopentetic acid and gadoversetamide should be suspended in the EU, the agency said. But the suspensions or restrictions on linear agents can be lifted if companies 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.

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