2017-04-20 17:12:06 - 8

ACR disagrees with European recommendation on gadolinium; European decision will be reviewed

The American College of Radiology (ACR) Committee on Drugs and Contrast Media has disagreed with the recently published recommendation by the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) to withdraw four MRI contrast agents. gadolinium-based products (GBCAs) on the market. The ACR committee said that while tissue retention of gadolinium after intravenous administration of GBCA has recently been reported, it has been known for over 10 years that some gadolinium chelates are not completely stable.in vivo. The ACR expressed that it continues to highlight the need for additional research aimed at a greater understanding of the mechanisms, cellular effects, and clinical consequences of gadolinium tissue deposition.   European committee agrees to review decision At a meeting held April 3-6, the PRAC said it will initiate a reexamination of its recommendation in response to requests from contrast developers affected by the decision. Under EMA rules, companies affected by recommendations can request a review. The PRAC expects the review to be completed in July. Source: Aunt Minnie