After evaluating the risk of brain deposits with repeated use of gadolinium-based contrast agents for magnetic resonance imaging (MRI), the Food and Drug Administration (FDA) has concluded that restricting their usE Is not warranted.
GBCAs are intravenous (IV) drugs used in diagnostic imaging procedures to enhance the quality of MRI or magnetic resonance angiography. In July 2015, the FDA announced plans to investigate the potential risk with GBCAs.
For the review, the FDA analyzed scientific literature and adverse event reports. Some of these studies evaluated GBCA use for durations >1 year and showed that gadolinium is retained in organs such as the brain, bones, and skin; linear GBCAs were shown to retain more gadolinium in the brain vs. macrocyclic GBCAs. The review, however, did not find adverse health effects related to retained gadolinium in the brain.
The only known adverse health effect related to gadolinium retention is a rare condition called nephrogenic systemic fibrosis (NSF) that is seen in a small group of patients with pre-existing renal failure. The FDA is continuing to evaluate whether fibrotic reactions are an adverse effect of retained gadolinium.
The FDA’s recommendations remain the same from July 2015. Clinicians should limit use of GBCAs to situations where additional information provided by the contrast agent is needed and assess the necessity of repeat MRIs with GBCAs.
Currently, the FDA-approved GBCAs are:
- Ablavar (gadofosveset trisodium)
- Dotarem (gadoterate meglumine)
- Eovist (gadoxetate disodium)
- Gadavist (gadobutrol)
- Magnevist (gadopentetate dimeglumine)
- MultiHance (gadobenate dimeglumine)
- Omniscan (gadodiamide)
- OptiMARK (gadoversetamide)
- ProHance (gadoteridol)
The labeling for OptiMARK (gadoversetamide), a linear GBCA, has been updated with data about gadolinium retention in various organs; the FDA is reviewing all GBCAs to determine if updates to labeling are needed. Gadolinium retention does not apply to other scanning agents (eg, iodine-based, radioisotopes) used for other imaging procedures.
The Agency is conducting a study on brain retention of GBCAs in rats, and other ongoing research is evaluating how gadolinium is retained in the body. The FDA will update the public as new information becomes available.
For more information visit FDA.gov.