MHRA suspends use of certain Gadolinium contrast agents (GdCAs), and restricts uses of others

MHRA suspends use of certain Gadolinium contrast agents (GdCAs), and restricts uses of others

14 December 2017 : The MHRA is suspending licenses for gadodiamide (Omniscan) and intravenous gadopentetic acid (Magnevist), and is restricting the use of gadobenic acid (also known as gadobenate dimeglumine; MultiHance) and gadoxetic acid (Primovist) to delayed phase liver imaging only.

‘Macrocyclic’ GdCAs such as ProHance, Gadovist and Dotarem, are not suspended, but product information for these agents is being updated.

Investigators using any GdCAs in clinical research studies (including both CTIMPs and non-CTIMPS) Sponsored by the University of Edinburgh and/or NHS Lothian should be aware of these updates and suspensions, and consult the MHRA information provided in the link below to confirm if their particular GdCA is affected. Investigators involved with University of Edinburgh and/or NHS Lothian sponsored studies can contact the ACCORD Pharmacovigilance team (safety@accord.scot) if they require any further assistance.

MHRA link to further information