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Pharmacogenomic biomarker information in FDA-approved paediatric drug labels

Therasa Kim1, Nayoung Han, Minji Sohn

  • 1College of Pharmacy, Chonnam National University, Gwangju, South Korea.

Basic & Clinical Pharmacology & Toxicology
|October 29, 2014
PubMed

Insights

Pediatric pharmacogenomic data is lacking, with adult information often used in FDA-approved drug labels for children. More pediatric-specific pharmacogenomic studies are needed to ensure safe and effective drug use in this population.

Area of Science:

  • Pharmacogenomics
  • Pediatric Pharmacology
  • Biomarker Discovery

Background:

  • Gene expression and physiological maturation differ significantly between pediatric and adult populations.
  • Extrapolation of adult pharmacogenomic data to pediatric patients may not be appropriate, necessitating specific research.
  • Current FDA-approved drug labels often rely on adult pharmacogenomic information for pediatric use.

Purpose of the Study:

  • To assess the translation of pediatric pharmacogenomic trial findings into US FDA-approved drug labels.
  • To identify the need for dedicated biomarker studies in pediatric pharmacogenomics.
  • To evaluate the current landscape of pediatric pharmacogenomic research.

Main Methods:

  • Analysis of FDA's Table of Genomic Biomarkers and Drugs@FDA database for relevant drug labels.
  • Comparison of labeled biomarkers against PharmGKB's Very Important Pharmacogenes (VIPs) database.
  • Review of FDA product reviews and ClinicalTrials.gov for pediatric pharmacogenomic studies.

Main Results:

  • Out of 56 drugs with potential pediatric pharmacogenomic application, only eight Very Important Pharmacogenes (VIPs) were labeled in 41 drugs.
  • Only three product reviews (out of 139 examined) focused on pharmacogenomic content, specifically CYP2C19 polymorphisms in proton pump inhibitors.
  • Pantoprazole was the only drug with pharmacogenomic information derived from pediatric trials; few pediatric pharmacogenomic studies are registered on ClinicalTrials.gov.

Conclusions:

  • There is a significant lack of pharmacogenomic studies conducted directly in pediatric patients.
  • FDA-approved labels commonly include pharmacogenomic information based on adult studies for pediatric use.
  • Conducting pediatric-specific pharmacogenomic studies is crucial, especially when significant biomarkers are identified, to optimize drug therapy in children.

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