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
“little 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 VIIa, and nesiritide.
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