The FDA announced Dec. 19 that it’s requiring a new class warning and additional safety measures for all gadolinium-based contrast agents (GBCAs) concerning gadolinium remaining in patients "for months to years after receiving these drugs."
The FDA notes that gadolinium retention has not been directly linked to negative health effects in patients who have normal kidney function. The FDA also stated the benefits of GBCAs outweighs potential risks. However, recent review and consultation with the Medical Imaging Drugs Advisory Committee has prompted further action to alert health care professionals and patients about gadolinium retention after MRI.
New changes to the labeling of all GBCAs has also been ordered by the FDA. The new labeling will now require a warning and precaution description related to gadolinium retention in the Adverse Reactions, Pregnancy, Clinical Pharmacology, and Patient Instructions sections.
Patients who are pregnant, children or have inflammatory conditions have a higher risk for gadolinium retention. The FDA advises healthcare professionals consider retention characteristics when choosing a GBCA. Additionally, patients and caregivers are advised to carefully read the FDA's new Medication Guide, which explains the risks associated with GBCAs.
"We are continuing to assess the health effects of gadolinium retention in the body and will update the public when new information becomes available," stated the FDA safety announcement issued on Dec. 19.
See the FDA's entire safety announcement for more information about class warnings and GBCA brands and information.