Unapproved Pediatric Drugs: Evidence for Use

摘要

The subspecialty of pediatric anesthesiology and critical care has seen remarkable growth over the past 20 to 30 years with establishment of fellowship programs, the recognition of the need for accreditation of these programs, the institution of a formal written examination and board certification in pediatric critical care, and the increasing recognition of the value of such subspecialists outside of our own arena. The recognition that neonates, infants, and children may require subspecialists to provide their intraoperative care has partly grown from the acceptance that the anatomy, physiology, and pharmacology of pediatric patients differ from those of their adult counterparts. That being said, it becomes obvious that children are not just "litde adults" and that variability in the response to many pharmaceutical agents is just one of many variations that may exist in this population. The following article reviews the potential for and history of unrecognized toxicity of newly released pharmaceutical agents; discusses the birth of the US Food and Drug Administration (FDA) and its current role in the regulation of drug use in pediatric patients; and presents data regarding three potentially useful yet non-FDA-approved medications in infants and children, including dexmedetomidine, recombinant factor VIla, and nesiritide.