A US FDA advisory committee agreed with the agency's plan to add a warning to the labeling of gadolinium-based contrast agents about the potential consequences of gadolinium retention in the brain and other body organs.
The agency has concluded that a causal connection has not been established between gadolinium retention and reported symptoms in patients with normal renal function who received the contrast agent. But reports to the FDA Adverse Event Reporting System (FAERS) and in the medical literature have raised concerns about retention and the agency asked the committee whether its plan to revise the labeling and recommend risk minimization steps for certain patient populations is the appropriate action to take
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