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Gadolinium-Based Contrast Agents & Seizure

    Basic Details
    Last Updated
    Tuesday, July 26, 2022
    Original Posting Date
    Health Outcome(s)
    Drug and Outcome Analysis
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    Gadolinium-based contrast agents (GBCA) are used in magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA) diagnostic imaging procedures to aid in the visualization of abnormalities. GBCAs have a warning for hypersensitivity reactions, and seizure risk is listed as a postmarketing adverse event. The FDA identified cases of seizures shortly following GBCA exposure in the FDA Adverse Event Reporting System (FAERS) case reports and initiated a Sentinel study to better understand the magnitude of seizure risk associated with exposure to GBCAs during MRI and MRA procedures. An increased risk of seizure was not observed comparing contrast to non-contrast MRI in this study (RR=1.04, 95% CI 0.62-1.61). FDA determined that current labeling was sufficient to communicate that seizures have been observed in the post-market setting.