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Gadolinium-Based Contrast Agents & Seizure

Basic Details
Status
Complete
Last Updated
Tuesday, July 26, 2022
Original Posting Date
Health Outcome(s)
seizure
Purpose
Drug and Outcome Analysis
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
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.

Analytic Code Link(s) (1)
Seizures Following Gadolinium-Based Contrast Agents Exposure: A Self-Controlled Risk Interval Analysis
Result(s) (7)
MRI and GBCA Procedures Same Day Seizures following Gadolinium Based Contrast Agents: A Self-Controlled Risk Interval Analysis Seizures Following Gadolinium-Based Contrast Agents Exposure: A Self-Controlled Risk Interval Analysis Coding Trend Analyses: Epilepsy - Inpatient Care Setting Coding Trend Analyses: Epilepsy - Emergency Department Care Setting Coding Trend Analyses: Convulsions - Inpatient Care Setting Coding Trend Analyses: Convulsions - Emergency Department Care Setting
Related Publication(s) and/or Presentation(s) (1)
Presentation: Integrating Sentinel into Routine Regulatory Drug Review: A Snapshot of the First Year