Advances in Pediatric Pharmacology, Therapeutics, and Toxicology

Abstract

Significant advancements have been made in pediatric therapeutics and pharmacology over the last two years. In the United States, passage of the Food and Drug Administration Safety and Innovation Act has made the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act permanent, and ensured that studies will be conducted in neonates. In Europe, the Pediatric Regulation, which went into effect in early 2007, has also provided a framework encouraging an expansion of pediatric research. Because of such regulatory involvement, a greater number of studies are being performed, and more pediatric dosing, efficacy, and safety information is being incorporated into product labels. The goal of this publication is to highlight important advancements made in the field of pediatric pharmacology, toxicology, and therapeutics from

A Study of Drug Detection in a Postmortem Pediatric Population

“…Children's cold medications containing diphenhydramine are not recommended for children under 6 years old, adult formulations are inadvisable for those under 12 years of age (18). In recent years, the National Institute of Child Health and Human Development (NICHD) has been working with the FDA to establish appropriate labeling on over-the-counter medicines for neonates and infants to clarify dosing for these individuals (19). For the 271 cases occurring in the age category 1 day-2 years, one death was determined to be related to antihistamine use.…”