Media Release: Guerbet

• Published in: MediaNet Press Release Wire p. 1
• Format: Newsletter
• Language: English
• Published: Sydney Medianet 10.02.2007

The reinforced usage precautions apply to all gadolinium-based contrast media used in MRI. As a result, the summary of product characteristics (SPC) of Dotarem(R) (Gadoteric acid, Guerbet) has been modified. Up until now, no case of nephrogenic systemic fibrosis has yet been linked to DOTAREM(R). As no case of nephrogenic systemic fibrosis has up until now been reported among patients who have received DOTAREM(R), the EMEA has demanded only the addition in the SPC of a precaution for using DOTAREM(R) among patients suffering from chronic renal failure. The tolerance of DOTAREM(R) on the clinical level and its diagnostic interest were the subject of a scientific article that appeared in January 2007 in the Investigative Radiology (10) journal. The study was carried out in Germany among 24,308 patients who had benefited from an MRI scan between January 2004 and October 2005. Secondary effects, observed in only 0.4% of cases, limited themselves mainly to feelings of heat, nausea or a short-term change in taste. Only one serious event was reported, which was not connected to nephrogenic systemic fibrosis and there were no repercussions for the patient. DOTAREM(R) is indicated for adults, children and infants for magnetic resonance imaging for cerebral and medullary pathologies, rachis pathologies and other whole-body pathologies (including angiography). Largely commercialized around the world since 1989, DOTAREM(R) has been administered to more than 10 million people who have benefited from an MRI scan. The approved indications for Dotarem(R) can vary between countries.