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Obesity Considerations in Pediatric Drug Development, 2016-2021
Sherbet Samuels1, Varsha Bhatt-Mehta1, Kyunghun Park2
1Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Journal of Clinical Pharmacology
|November 9, 2023
Summary
Pediatric obesity impacts drug effectiveness. A review found few drug products address pharmacokinetic changes in obese children, highlighting a critical need for more research and guidelines for safe medication use.
Area of Science:
- Pharmacology
- Pediatrics
- Public Health
Background:
- Pediatric obesity is a growing global health issue.
- Obesity can alter drug pharmacokinetics, potentially causing treatment failure or toxicity in children.
- Previous reviews indicated limited pharmacokinetic data for obese pediatric populations in drug development.
Approach:
- Analyzed 185 drug products submitted to the US FDA between 2016-2021 for obesity considerations.
- Queried FDA review documents and drug product labeling for obesity-related terms.
- Assessed the extent and nature of obesity-related information, particularly regarding pharmacokinetics.
Key Points:
- Over half (52%) of reviewed drug products mentioned obesity, but only 7% specifically addressed pharmacokinetics in labeling.
- Most obesity information in labeling originated from adult data, not pediatric studies.
- Specific dosage guidance for obese pediatric patients is largely absent.
Conclusions:
- There is a significant lack of information on drug pharmacokinetics and dosing for obese children.
- Further research, innovative strategies, and evidence-based guidelines are crucial.
- Optimizing drug therapy for obese pediatric patients requires dedicated investigation.
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