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Related Experiment Video

Updated: Jun 16, 2026

An Investigation of the Effects of Sports-related Concussion in Youth Using Functional Magnetic Resonance Imaging and the Head Impact Telemetry System

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A Comprehensive Disproportionality Analysis of Drug-Related Head Injury Reports Using the FAERS Database.

Jiaqi Guo¹, Luming Wei², Junfeng Liu³

¹Department of Orthopedics, The Affiliated Hospital of Beihua University, Jilin City, China.

Brain and Behavior

|June 15, 2026

Summary

Coagulation factor therapies and chamomile show strong associations with head injury reports in a large FDA safety database analysis. These findings suggest potential risks requiring further clinical investigation and vigilance.

Keywords:

FAERS database disproportionality analysis head injury pharmacovigilance potential risks

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An Investigation of the Effects of Sports-related Concussion in Youth Using Functional Magnetic Resonance Imaging and the Head Impact Telemetry System

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A Test Bed to Examine Helmet Fit and Retention and Biomechanical Measures of Head and Neck Injury in Simulated Impact

A Test Bed to Examine Helmet Fit and Retention and Biomechanical Measures of Head and Neck Injury in Simulated Impact

Published on: September 21, 2017

Area of Science:

Pharmacovigilance
Drug Safety Analysis
Adverse Event Reporting Systems

Background:

Head injuries are a significant public health concern.
Understanding drug-associated risks is crucial for patient safety.
The FDA Adverse Event Reporting System (FAERS) is a valuable resource for pharmacovigilance.

Purpose of the Study:

To identify and characterize drugs linked to head injury reports using the FAERS database.
To analyze trends and safety signals associated with head injury events.

Main Methods:

Retrospective disproportionality analysis of FAERS data (2004-2023).
Identification of head injury cases using MedDRA Preferred Term.
Application of four disproportionality methods (ROR, PRR, BCPNN, MGPS) for signal detection.

Main Results:

Analysis of 26,485 head injury reports revealed an increasing trend, with 84.12% serious and 8.51% fatal events.
Strongest safety signals for head injury were associated with coagulation factors (vonicog alfa, pegylated factor VIII) and chamomile.
Warfarin had the highest report count but a moderate signal strength.

Conclusions:

Coagulation factor therapies show a strong association with head injury reports, likely due to confounding by indication.
Chamomile also presents a significant safety signal warranting further investigation.
Increased clinical vigilance and further research are needed to address these identified risks.