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Pharmacovigilance

Pharmacovigilance

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Drug distribution in the pediatric population exhibits unique challenges and considerations due to the physiological differences between children, particularly neonates and infants, and adults. A crucial aspect of pediatric pharmacology is understanding how these differences impact the pharmacokinetics of various drugs, necessitating age-specific dosing strategies to ensure efficacy and safety.Neonates and infants have a higher total body water content, ~75%–90% of their body weight,...

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Evidence-based Knowledge Synthesis and Hypothesis Validation: Navigating Biomedical Knowledge Bases via Explainable AI and Agentic Systems

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Identifying Pediatric Drug Safety Knowledge Gaps: An Integrated Approach Leveraging Real-World Data, a Biomedical

Saurabh Rahurkar^1,2, Jiayi Ouyang¹, Pallavi Jonnalagadda¹

¹Department of Biomedical Informatics, College of Medicine, The Ohio State University, Columbus, Ohio, USA.

Pharmacotherapy

|October 1, 2025

Summary

Benzonatate, a common cough medicine, has limited safety data and a high risk of serious adverse drug events (ADEs) in children. Further research is needed to ensure its safe use in pediatric populations.

Keywords:

adverse drug events drug safety real‐world data real‐world evidence therapeutic orphans

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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

Area of Science:

Pediatric pharmacology
Pharmacoepidemiology
Drug safety surveillance

Background:

Pediatric populations are often
therapeutic orphans
due to understudied drug safety.

Purpose of the Study:

To identify high-impact drugs with limited safety evidence and high risk of serious adverse drug events (ADEs) in pediatric populations.
To address the disconnect between clinical practice and safety data for pediatric drug use.

Main Methods:

Integrated multiple databases: Merative MarketScan, MPRINT Knowledgebase, FDA Adverse Event Reporting System (FAERS), and FDA drug labels.
Defined high-impact targets as drugs with high prescription volume, limited safety evidence, and high risk of serious ADEs.

Main Results:

Benzonatate was identified as a high-impact drug of concern.
Benzonatate has limited safety publications (9 studies in six decades) despite high prescription volume.
Serious ADEs associated with benzonatate include seizure, death, and arrhythmia, with high proportional reportion ratios (PRRs).

Conclusions:

Benzonatate has limited safety evidence and is frequently prescribed off-label with questionable effectiveness and high risk of serious ADEs.
There is a critical need to study benzonatate's safety using real-world data.
The study presents a systematic, data-driven approach to prioritize drug-ADE combinations with limited evidence.