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ACR disagrees with European gadolinium recommendation; European decision will be reviewed

The American College of Radiology (ACR) Medicines and Contrast Committee disagreed with the recommendation recently issued by the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) to withdraw four MRI contrast agents based gadgets (GBCAs) on the market.

The ACR committee said that although gadolinium tissue retention following intravenous administration of GBCA has recently been reported, it has been known for some 10 years that some gadolinium chelates have not been completely stable.in vivo.

The ACR stated that it continues to highlight the need for further research directed at a greater understanding of the mechanisms, cellular effects and clinical consequences of gadolinium tissue deposition.

 

European committee agrees to review decision

At a meeting held April 3-6, PRAC said it would initiate a review of its recommendation in response to requests from contrast developers affected by the decision. Under EMA rules, companies affected by recommendations may request a review. The PRAC expects the review to be completed in July.

Source: AuntMinnie

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Written by

Thiago Braga

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