FDA Drug Safety Communication for All Gadolinium Based Contrast Agents
The U.S. Food and Drug Administration (FDA) is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) concerning gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs. Gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function, and the FDA has concluded that the benefit of all approved GBCAs continues to outweigh any potential risks.
However, after additional review and consultation with the Medical Imaging Drugs Advisory Committee, the FDA is requiring several actions to alert health care professionals and patients about gadolinium retention after an MRI using a GBCA, and actions that can help minimize problems. These include requiring a new patient Medication Guide, providing educational information that every patient will be asked to read before receiving a GBCA. The FDA is also requiring manufacturers of GBCAs to conduct human and animal studies to further assess the safety of these contrast agents.
To date, the only known adverse health effect related to gadolinium retention is a rare condition called nephrogenic systemic fibrosis (NSF) that occurs in a small subgroup of patients with pre-existing kidney failure. However, FDA has also received reports of adverse events involving multiple organ systems in patients with normal kidney function. A causal association between these adverse events and gadolinium retention could not be established.
Health care professionals should consider the retention characteristics of each agent when choosing a GBCA for patients who may be at higher risk for gadolinium retention. These patients include those requiring multiple lifetime doses, pregnant women, children, and patients with inflammatory conditions. Minimize repeated GBCA imaging studies when possible, particularly closely spaced MRI studies. However, do not avoid or defer necessary GBCA MRI scans.
Patients, parents, and caregivers should carefully read the new patient Medication Guide that will be given to them before receiving a GBCA. The Medication Guide explains the risks associated with GBCAs. Health care professionals should obtain the following information from patients/parents/caregivers:
- Pregnancy or possibility/suspicion of pregnancy
- Date of last MRI with gadolinium, history of repeat scans with gadolinium
- History of kidney problems
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
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