Wayne Vallee, R.Ph., MBA, RAC

Although children suffer from many of the same diseases as adults and are often treated with the same drugs, only a small fraction of the drugs marketed and used as therapies in the United States have been studied in pediatric patients 0–16 years of age. Recent data demonstrates that only about 25% of approved drugs marketed in the United States have adequate pediatric data to support approval of product labeling by FDA for dosing, safety, or efficacy in children. This lack of appropriate pediatric testing and labeling increases the chances of incorrect dosing, thereby exposing pediatric patients to either an increased risk of adverse reactions or less than optimal therapeutic benefits.