Italia

News

Mezzi di contrasto a base di gadolinio: aggiornamento sulle raccomandazioni PRAC

05.04.2017 12:06

Villepinte, 13 Marzo 2017 - Guerbet (FR0000032526 GBT), prende atto delle raccomandazioni diffuse dal comitato di Valutazione dei Rischi per la Farmacovigilanza (PRAC) sui mezzi di contrasto a base di gadolinio secondo quanto dettato dall’articolo 31 della Direttiva 2001/83/EC.

Dopo quasi un anno di revisione approfondita del rischio di deposito nel tessuto cerebrale e in generale della sicurezza di tali prodotti, le  raccomandazioni del PRAC1 sono le seguenti: 

“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.”

Leggi il comunicato stampa.

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