The FDA has issued a communication to healthcare professionals and patients in the United States to inform them that the FDA is requiring changes in the professional labelling for gadolinium-based contrast agents (GBCAs) to minimise the risk of nephrogenic systemic fibrosis (NSF). This is a rare, but serious, condition associated with the use of GBCAs in certain patients with renal dysfunction. Symptoms of NSF include scaling, hardening and tightening of the skin; red or dark patches on the skin; and stiffness. The condition can also cause fibrosis of internal organs which may lead to death.

The FDA is recommending that healthcare professionals should screen patients prior to administration of a GBCA to identify those with acute kidney injury or chronic, severe, kidney disease.

Further information can be found via the links below, including detailed recommendations for healthcare professionals and a Q&A document.