Gadolinium-based Contrast Agents: update on PRAC recommendations

30.03.2017 10:00

Villepinte, March 13, 2017 - Guerbet takes note of the recommendations issued by the Pharmacovigilance Risk Assessment Committee (PRAC), on Gadolinium-based Contrast Agents - procedure under Article 31 of Directive 2001/83/EC.

After carrying out an almost year-long in-depth review of the risk of brain deposits and of the overall safety of these products, the PRAC recommendationsare as follows:

“EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) has recommended the suspension of the marketing authorisations for four linear gadolinium contrast agents because of evidence that small amounts of the gadolinium they contain are deposited in the brain.
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. (...)
The four agents recommended for suspension are referred to as linear agents. Linear agents have a structure more likely to release gadolinium, which can build up in body tissues.
Other agents, known as macrocyclic agents, are more stable and have a much lower propensity to release gadolinium. The PRAC recommends that macrocyclic agents2 be used at the lowest dose that enhances images sufficiently to make diagnoses and only when unenhanced body scans are not suitable.”

Read the press release

1. Gadolinium Article-31 referral - PRAC concludes assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorisations. 10/03/2017

2. Gadobutrol, gadoteric acid and gadoteridol