Risk of gadolinium brain deposits associated with use of gadolinium-based contrast agents

HSA, in consultation with its Product Vigilance Advisory Committee, would like to update healthcare professionals on the outcome of its review regarding the potential risk of gadolinium deposition in the brain following repeated use of gadolinium-based contrast agents (GBCA). There has been increasing scientific evidence of gadolinium deposition in the brain following the use of GBCAs (particularly the linear agents) during magnetic resonance imaging scans. HSA's review concluded that while there is currently no definite evidence of clinical harm of gadolinium brain deposition following GBCA administration, healthcare professionals are advised to use the lowest effective dose of GBCA whenever possible and repeated doses of GBCAs should only be administered after careful benefit-risk assessment. HSA will be working with the companies to strengthen the local package inserts of GBCAs to warn of the potential risk of gadolinium brain deposits and will continue to closely monitor the international and local developments of this issue and update healthcare professionals of any new significant findings. Please refer to the letter for details.