Investigating the safety of off-label drugs used in children
Safety of Drugs Commonly Used Off-Label in Children Despite Insufficient Evidence of Efficacy and Safety
This study is looking into how safe and effective certain medications, often used for mental health issues in kids, really are when they're prescribed in ways not officially approved, so we can help doctors make better choices for treating children.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Rutgers Biomedical and Health Sciences NIH-funded |
| Lab location | 1 site (Newark, UNITED STATES) |
| Project ID | NIH-11130911 on NIH RePORTER |
What this research studies
This research focuses on the safety and effectiveness of drugs that are commonly used off-label in children, particularly psychotropic medications. It aims to assess the risks associated with these drugs, which are often prescribed without sufficient evidence of their efficacy or safety for pediatric use. The study will analyze the potential serious drug-related harms that may arise from the use of these medications in children, with the goal of informing better clinical decision-making and improving child health outcomes. By understanding the implications of off-label drug use, the research seeks to promote safer treatment options for children.
Who could benefit from this research
Good fit: Ideal candidates for this research include children under 11 years old who are prescribed psychotropic medications off-label.
Not a fit: Patients who are not using off-label medications or those over the age of 11 may not receive benefit from this research.
Why it matters
Potential benefit: If successful, this research could lead to safer prescribing practices for children, reducing the risk of serious drug-related harms.
How similar studies have performed: Previous research has highlighted the risks associated with off-label drug use in children, indicating that this area is critical for further investigation.
Where this research is happening
Newark, UNITED STATES
- Rutgers Biomedical and Health Sciences — Newark, United States (Active)
Researchers
- Principal investigator: Horton, Daniel Benjamin — Rutgers Biomedical and Health Sciences
- Study coordinator: Horton, Daniel Benjamin
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.