The Food and Drug Administration (FDA) is investigating the safety risk associated with repeated use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI).
Recent reports have shown presence of GBCA deposits in the brain in patients who undergo four or more contrast MRI scans. While GBCAs are mostly renally cleared, trace amounts can remain in the body long-term even in individuals with normal kidney function. Currently, the adverse effects of long-term GBCA deposits in the body are unknown.
The FDA is not requiring that changes be made to the label until more information becomes available regarding its potential health effects. However, it is recommended that its use be limited to situations where the additional information provided by the contrast is necessary. Healthcare professionals should re-evaluate the need for procedure when following treatment protocols. This issue does not apply to other scanning agents used in other imaging procedure (eg, iodine-based, radioisotopes).
For more information call (888) 463-6332 or visit FDA.gov.