Contrast agent manufacturer Bracco said it still believes in the risk-benefit balance of its MultiHance MR contrast agent, despite a recommendation from European regulators that it and three other linear gadolinium-based contrast agents (GBCAs) be removed from the market due to concerns over gadolinium retention in the body.
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended on 10 March that the marketing authorizations for MultiHance and three other GBCAs be suspended because of evidence that small amounts of gadolinium may be retained in brain tissues after intravenous use. However, Bracco said the PRAC took this precautionary approach in the absence of known symptoms or diseases linked to gadolinium residue in the brain.
Furthermore, the recommendation doesn't represent the final decision of the European authorities on the risk-benefit balance of the GBCAs available in the European Union (EU), according to Bracco. The final position will actually be taken at the end of a regulatory procedure called referral, and additional assessments will be made to complete this procedure to arrive at the final decisions on the various GBCAs, the company said.
In the meantime, Bracco said it will stay focused during the next steps of the referral procedure on all of the available evidence on gadolinium retention. It also continues to be fully committed to support regulatory authorities in their assessments and to foster advances in scientific knowledge in the best interest of patients, according to the firm.
Bracco also emphasized the PRAC opinion has no impact on the ongoing validity of the current marketing authorization for MultiHance. The agent will remain fully available for clinical use in the approved indications during the referring procedure, the vendor said.
