Pharmacy Services Alerts
Gadolinium-based contrast agents: updated warning concerning prolonged retention in the body
Jan 2, 2018 12:22 PM
**Due to an update in May 2019 to the FDA.gov website, provided links may not appropriately redirect. Please visit www.fda.gov/drugs/drug-safety-and-availability to see the most recent FDA Medication Safety Alerts and Safety Communications or to search for specific alerts or communications.**
Gadolinium-based contrast agents (GBCAs) can remain in patients’ bodies for months to years after administration. The FDA issued a safety alert in May 2017 describing the retention of gadolinium in organs such as the brain, bones, and skin. They did not identify any adverse health events related to gadolinium retention in the brain at that time. In this updated safety alert, the FDA provided further information that gadolinium retention has not been associated with adverse events in patients with normal renal function. The only documented adverse effect associated with GBCAs is a rare condition called nephrogenic systemic fibrosis in patients with kidney failure. The FDA reaffirmed their previous decision that the benefits of GBCAs continue to outweigh the risks.
The FDA is requiring a new patient Medication Guide describing the risk of gadolinium retention, which every patient will be asked to read prior to receiving GBCAs. Healthcare providers are encouraged to review the retention characteristics of GBCAs, particularly when selecting agents for patients at higher risk for gadolinium retention (eg, children, pregnant women, patients with inflammatory conditions, and patients who will require multiple doses over their lifetime). Linear GBCAs retain more gadolinium in the brain and for a longer duration than macrocyclic GBCAs. The December 19th FDA alert linked below includes a table defining which products are linear and macrocyclic. Repeated GBCA imaging studies should be minimized when possible. Patients should tell their healthcare provider if they are pregnant, the date of their last MRI with gadolinium, their history of gadolinium use, and if they have kidney problems. To assess the ongoing safety of gadolinium retention, GBCA manufacturers are required to conduct human and animal studies. The FDA will update the public when any new information on gadolinium retention is available.
FDA requires the distribution of Medication Guides for drugs determined to be a serious and significant public health concern. Distribution requirements and exceptions (eg, certain inpatient care situations) for Medication Guides are addressed in an FDA Guidance Document: www.fda.gov/Drugs/DrugSafety/ucm085729.htm.
Medication Guide distribution requirements are stricter for medications with a Risk Evaluation and Mitigation Strategy (REMS) that includes Elements To Assure Safe Use (ETASU) with specific requirements for providing and reviewing the Medication Guide. A complete list of drugs that require a Medication Guide as part of the FDA-regulated product labeling is available online at: www.fda.gov/Drugs/DrugSafety/ucm085729.htm.
For more information:
- FDA Medwatch Alert – December 19, 2017
- FDA Safety Alert – December 19, 2017
- FDA Medwatch Alert – May 22, 2017
- FDA Safety Alert – May 22, 2017