Pediatr Crit Care Me
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Pediatr Crit Care Me · Sep 2011
Food and Drug Administration approval for medications used in the pediatric intensive care unit: a continuing conundrum.
Many drugs used in the pediatric intensive care unit are administered "off label," i.e., they have been neither thoroughly tested for efficacy and safety nor approved for use in children. The U.S. Congress has enacted legislation to promote standards and requirements for Food and Drug Administration labeling for drugs used in pediatrics. Nevertheless, we hypothesized that most medications used in our pediatric intensive care unit were not Food and Drug Administration approved for use in pediatric patients. ⋯ Despite the efforts of Congress, 67% of medications prescribed and administered in the pediatric intensive care unit did not have Food and Drug Administration approval or had only limited approval, underscoring the need for the medical community to demand oversight and research to improve drug labeling for our patient population.