BioCentury
ARTICLE | Clinical News

Eovist gadoxetate disodium regulatory update

December 14, 2009 8:00 AM UTC

EMEA's CHMP concluded a review of gadolinium-based contrast agents used with MRI scans and issued recommendations regarding the risk of nephrogenic systemic fibrosis, a rare disorder causing a thickening of skin and connective tissues in patients with severe kidney problems. The agency said products classified as high-risk should be dosed at the minimum recommended dose and not be used in patients with severe kidney problems or those undergoing liver transplantation, or in newborns. The labels for medium- and low-risk agents will be modified to include additional warning language. CHMP also recommended further studies on the long-term retention of gadolinium in human tissues. ...