FDA: New Med Guide for Patients Receiving Gadolinium-Based Contrast Agents
A Medication Guide should be provided to any patient who requests the information.
The Food and Drug Administration (FDA) has approved new patient Medication Guides for all gadolinium-based contrast agents (GBCA). These Medication Guides should be provided the first time an outpatient receives a GBCA injection at an MRI center; hospital patients are not required to receive a Medication Guide.
"A healthcare professional who determines that it is not in a patient's best interest to receive a Medication Guide because of significant concerns about its effects may direct that it not be provided to that patient; however, the Medication Guide should be provided to any patient who requests the information," the Agency stated in their safety communication.
The approval is part of a set of actions the Agency put forth to inform patients about the potential risks associated with GBCAs. In December 2017, the FDA announced a new class warning regarding the risk of gadolinium retention after an MRI when GBCAs are used. In this update, clinicians were advised to consider the retention characteristics of an agent before choosing a GBCA for a patient.
Of the two types of GBCAs—linear and macrocyclic—the linear GBCAs have greater and longer retention compared to macrocyclic GBCAs. Specifically, gadolinium levels retained in the body are higher after receiving Omniscan (gadodiamide) or OptiMARK (gadoversetamide) compared with Eovist (gadoxetate disodium), Magnevist (gadopentetate dimeglumine), or MultiHance (gadobenate dimeglumine). The lowest levels of retained gadolinium were associated with Dotarem (gadoterate meglumine), Gadavist (gadobutrol), and ProHance (gadoteridol).
Patients at risk for retention may include pregnant women, those requiring multiple lifetime doses, children, and patients with inflammatory conditions. While repeated imaging studies should be kept to a minimum (particularly closely spaced MRIs), the FDA cautions against avoiding or delaying necessary GBCA MRI scans. The only established adverse effect associated with gadolinium retention is nephrogenic systemic fibrosis; a causal relationship has not been established.
For more information visit FDA.gov.