FDA votes for further warnings for gadolinium-based contrast agents
In July 2017, the European Medicines Agency (EMA) sent a recommendation to the EU Commission to issue a legally binding decision regarding restrictions on the use of certain gadolinium-based contrast agents for MRI and to completely prohibit the use of others. The decision is based on a scientific review by the EMA Pharmacovigilance Risk Assessment Committee, PRAC, which concludes that gadolinium may accumulate in the brain and other tissues after using gadolinium-containing contrast agents.
After taking a “wait and see”-attitude, the US food and drug administration FDA is now expected to take further regulatory measures regarding the use of gadolinium-based contrast agents. The FDA Medical Imaging Drugs Advisory Committee, MIDAC, voted on September 8th for the FDA to include warnings for gadolinium retention in certain tissues to the labels of gadolinium-based contrast agents. In addition, MIDAC voted with overwhelming majority to have the FDA require that manufacturers of gadolinium-based contrast agents carry out clinical trials to determine whether additional regulatory measures are required, including withdrawal of market authorisation or restrictions of use in certain populations.
Spago Nanomedical’s contrast agent for MRI, SpagoPix, is gadolinium-free.