Several challenges complicate pediatric drug labeling:
1. Lack of Clinical Trials: There is often a shortage of robust clinical trials involving children, leading to gaps in knowledge. 2. Ethical Concerns: Conducting clinical trials in children poses ethical challenges, such as obtaining informed consent and ensuring minimal risk. 3. Variability in Drug Response: Children can respond differently to medications compared to adults due to their developing bodies and metabolic systems. 4. Formulation Issues: Many drugs are not available in pediatric-friendly formulations (e.g., liquid suspensions), making accurate dosing difficult.
