PRAC committee agrees to review gadolinium decision

A European regulatory committee that recommending pulling four linear-based gadolinium MRI contrast agents off the market said it has agreed to review the decision.

At a meeting held on 3-6 April, the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) said it will initiate a re-examination of its recommendation in response to requests from contrast developers affected by the decision. Under EMA rules, companies affected by recommendations are allowed to request a review. The PRAC expects the review will be completed in July.

The PRAC on 10 March recommended that the marketing authorizations for the four gadolinium agents be rescinded due to evidence of gadolinium accumulation in the brains of patients who had received the products. While no clinical issues have been connected to gadolinium deposition, the PRAC said the move was necessary as a "precautionary approach."

Reaction to the announcement has been mixed across the radiology industry, with some groups and vendors opposed the move, while at least one contrast vendor said it supported the decision.

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