- by Shannon Firth, Washington Correspondent, MedPage Today
SILVER SPRING, Md. — An FDA advisory committee voted 13-1, with one abstention, to recommend a new warning for gadolinium-based contrast agents (GBCAs) used in magnetic resonance imaging on Friday.
Specifically, the FDA’s Medical Imaging Drugs Advisory Committee recommended that prescribing information should include “a warning for retention for all GBCAs with greater retention of all or some of the linear GBCAs compared to the macrocyclics in certain organs including the brain,” and that “risk minimization steps” be taken for certain patient populations.
The FDA made a minor distinction between macrocyclic and linear GBCAs, noting the higher stability of the macrocyclics may cause them to “wash out” of the body; but the agency stressed that both agents leave behind deposits of gadolinium.
Agency leadership asked the committee for advice on how to weigh recent findings of gadolinium retention in the brain and other organs, and how to minimize potential risks moving forward. Virtually all committee members agreed that the evidence of retention in patients, to date, doesn’t indicate a definitive causal relationship with an array of symptoms reported in the FDA’s database and medical literature, beyond previously identified concerns for kidney patients (current labeling already includes a boxed warning and contraindications for this population).
In 2007, researchers uncovered a link between GBCAs and nephrogenic systemic fibrosis (NSF) — a debilitating condition, that impacts the skin, muscles and internal organs and is sometimes fatal — in kidney patients, however more recent evidence suggests patients without impaired renal function also show deposits of gadolinium in their central nervous system and throughout the body. As recently as June, researchers reported that gadolinium deposits were found in patients with normal brains — previously intracranial abnormalities were seen as responsible for the agents clinging to neural tissues.
