PRAC suspends four gadolinium agents, reviewing valproate and docetaxel

13 March 2017

At its March meeting, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded a safety review and started a new one for which there will be a public hearing. The PRAC also started the review of docetaxel-containing medicines in the context of a safety signal and discussed three ongoing referrals.

The PRAC has recommended the suspension of the marketing authorizations for four linear gadolinium contrast agents because of evidence that small amounts of the gadolinium they contain are deposited in the brain. Evidence has not shown signs of harm.

The agents concerned are intravenous injections of gadobenic acid, gadodiamide, gadopentetic acid and gadoversetamide, which are given to patients to enhance images from magnetic resonance imaging (MRI) body scans.

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