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Gadolinium-haltige MRT Kontrastmittel: Update zu den PRAC- Empfehlungen

24.03.2017 10:34

Guerbet gab die vom Ausschuss für Risikobewertung im Bereich der Pharmakovigilanz (PRAC) herausgegebenen Empfehlungen zu Kontrastmitteln auf Gadolinium-Basis bekannt - Verfahren gemäß Artikel 31 der Richtlinie 2001/83/EG.

Nach einer fast einjährigen umfassenden Prüfung des Risikos von Gehirnablagerungen sowie der allgemeinen Sicherheit dieser Produkte lauten die PRAC-Empfehlungen1 wie folgt:

“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.”

 
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Weitere Informationen finden Sie auf www.bfarm.de/SharedDocs/Risikoinformationen/Pharmakovigilanz/DE/RV_STP/g-l/gadolinium-kernspin-neu.html

 

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