• Best Pract Res Clin Anaesthesiol · Sep 2010

    Review

    Use of pharmaceuticals 'off-label' in the neonate.

    • Joseph R Tobin.
    • Department of Anesthesiology, Wake Forest University School of Medicine, Winston-Salem, NC, USA. jtobin@wfubmc.edu
    • Best Pract Res Clin Anaesthesiol. 2010 Sep 1; 24 (3): 451-60.

    AbstractNeonates are frequently not studied in the development of a novel pharmacological agent. With lack of data to support safe and effective use of a new agent in this population, sponsors will not receive approval for labelling the agent for use in this age group from the United States Food and Drug Administration (USFDA). This causes a significant conundrum for the clinician. Neonates are often precluded the benefits of new pharmaceuticals until investigators begin to report their clinical experience with novel agents. This article provides the clinician with an introductory understanding of the approval process of pharmaceuticals in the United States by USFDA. Models of clinical trial design are noted. Examples of anaesthetic and non-anaesthetic agents and their development and use are discussed as either 'labelled' or 'off-label' indications.

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