Improving pediatric dosing through pediatric initiatives: What we have learned
ABSTRACT The goal was to review the impact of pediatric drug studies, as measured by the improvement in pediatric dosing and other pertinent information captured in the drug labeling.
We reviewed the pediatric studies for 108 products submitted (July 1998 through October 2005) in response to a Food and Drug Administration written request for pediatric studies, and the subsequent labeling changes. We analyzed the dosing modifications and focused on drug clearance as an important parameter influencing pediatric dosing.
The first 108 drugs with new or revised pediatric labeling changes had dosing changes or pharmacokinetic information (n = 23), new safety information (n = 34), information concerning lack of efficacy (n = 19), new pediatric formulations (n = 12), and extended age limits (n = 77). A product might have had > or = 1 labeling change. We selected specific examples (n = 16) that illustrate significant differences in pediatric pharmacokinetics.
Critical changes in drug labeling for pediatric patients illustrate that unique pediatric dosing often is necessary, reflecting growth and maturational stages of pediatric patients. These changes provide evidence that pediatric dosing should not be determined by simply applying weight-based calculations to the adult dose. Drug clearance is highly variable in the pediatric population and is not readily predictable on the basis of adult information.
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ABSTRACT: Historically, systemic hypertension was felt to occur in 1–4% of children (1–5); however, the prevalence is now increasing because of the influence of childhood obesity (6,7). Over the past three decades, childhood obesity has increased dramatically and has been deemed an epidemic by the Centers for Disease Control and Prevention (8). The 2002 National Health and Nutrition Examination Survey reported that the prevalence of overweight and obese children aged 6–19 years was 31%, a 45% increase from the previous survey (9). Not only is the prevalence of pediatric hypertension increasing, but also the condition is frequently underdiagnosed (10,11). In younger children, hypertension is often secondary to an underlying disorder while primary (or essential) hypertension accounts for up to 95% of cases in adolescents (12,13). Hypertension in this age group is linked to obesity and risk factors associated with metabolic syndrome that can lead to cardiovascular disease in later life, including lipid abnormalities and insulin resistance. Obesity has been linked to comorbid conditions in children, including type 2 diabetes mellitus, hypertension, and hyperlipidemia (14,15).