FDA Evaluates Risk of Repeated Use of Gadolinium-Based Contrast Agents for MRI

Recent publications show that deposits of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) remain in the brains of some patients who have had four or more contrast MRI scans.  Generally the kidneys work to remove GBCAs from the body, but recent studies with humans and animals show that gadolinium can remain in the brain even in those with normal kidney function.  It is unknown if the deposits cause or can lead to any adverse events, and the FDA is working with the research community and industry to study the safety risk. 

Since there is a need for further information, the FDA is not requiring manufacturers to change labels of GBCA products.  However, it is recommended that health care professionals consider limiting GBCA use in order to reduce the potential of gadolinium buildup.

Here is the link to the FDA Safety Alert: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm456012.htm