WASHINGTON — All gadolinium contrast agents used in magnetic resonance imaging (MRI) must now carry a warning about their retention in the body, which has been linked to adverse renal effects, the FDA said Tuesday.
“The FDA reviewed available data about the retention of gadolinium from gadolinium-based contrast agents as part of its role in monitoring the post-market safety of drugs,” said Janet Woodcock, MD, director of the agency’s Center for Drug Evaluation and Research, in a statement. “As a result of that review, we recommend that health care professionals consider the retention characteristics of each agent when choosing a GBCA for patients who may be at higher risk, such as those who may require repeat GBCA MRI scans to monitor a chronic condition.”
In addition to the new label warning, the FDA is also requiring that manufacturers develop a Patient Medication Guide that patients will be asked to read before undergoing MRI scans using gadolinium agents.
These agents are usually metabolized and excreted into urine, but trace amounts can remain in the body for long periods, the FDA explained. This retention has been linked to nephrogenic systemic fibrosis in patients with pre-existing renal failure. While this effect appears to be rare, it is serious enough to warrant an advisory to all professionals and patients, the agency indicated.
The announcement Tuesday comes more than 2 years after the FDA said it was investigating reports of adverse events associated with gadolinium contrast agents.