7 PRAC members opposed EMA's gadolinium decision

Minutes published by the European Medicines Agency (EMA) have revealed that seven of the 34 members of the Pharmacovigilance Risk Assessment Committee (PRAC) spoke out against the decision to pull some gadolinium-based contrast agents from the market.

In July, the PRAC met to determine whether to stand by an earlier decision to withdraw certain linear gadolinium-based MRI agents. The committee ultimately stood by its decision, with some modifications, but the vote was not a unanimous one, according to the EMA's minutes.

A majority of 27 members voted to continue suspending gadodiamide (Omniscan, GE Healthcare), gadopentetic acid (Magnevist, Bayer), and gadoversetamide (Optimark, Guerbet). However, the July decision modified the use of gadobenate (MultiHance, Bracco), allowing it for liver imaging situations in which it would meet an important diagnostic need.

The PRAC members who opposed the decision have not been named, but the Norwegian member agreed with the recommendations, according to the minutes.

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