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The Need for Rigorous Evidence on Medication Use in Preterm Infants:  Is It Time for a Neonatal Rule?

Jonathan M. Davis, MD; Edward M. Connor, MD, MBE; Alastair J. J. Wood, MB, ChB
JAMA. 2012;308(14):1435-1436. doi:10.1001/jama.2012.12883.
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Approximately 200 000 infants born annually in the United States require admission to a neonatal intensive care unit for treatment of prematurity, costing more than $26 billion per year.1 Preterm infants are at substantial risk of death or developing serious morbidity that can affect them for life. Unlike treatments used in other fields of medicine, most medications administered to preterm infants lack convincing data to support their safety and efficacy with more than 90% not approved by the US Food and Drug Administration (FDA) for the prescribed indication. No new medications have substantially improved outcome for preterm infants since the introduction of antenatal corticosteroids and surfactant 15 to 20 years ago. Infants admitted to the neonatal intensive care unit may be exposed to more than 60 separate drugs, with the most premature infants receiving the greatest number of medications.2 Serious adverse drug reactions from single or multiple agents can significantly increase mortality and serious morbidity resulting in short- and long-term adverse consequences.3 It is important to solve this knowledge gap and define systems for drugs to be adequately studied. Without this, each preterm newborn is essentially being enrolled in an uncontrolled and unapproved clinical trial that will not yield data of substantial value.

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