RT Journal
A1 Kuehn BM
T1 LAws boost pediatric clinical trials, but report finds room for improvement
JF JAMA
JO JAMA
YR 2012
FD April 25
VO 307
IS 16
SP 1681
OP 1682
DO 10.1001/jama.2012.508
UL http://dx.doi.org/10.1001/jama.2012.508
AB 
Most drugs have never been studied in children, yet physicians often prescribe products studied in adults to children without the benefit of clinical evidence to support the safety and efficacy of the product for the patient's age group and without evidence-based information on dosing. Although this off-label use is a legal and accepted clinical practice, it can sometimes have unintended consequences. Physiological differences between adults and children may mean that a drug that is safe and effective in adults may not be so in children or that scaling down adult dosing regimens based on weight may not be appropriate. For example, the IOM report (http://tinyurl.com/6oqk65r) notes that in 1982, 16 premature infants died from respiratory complications after receiving intravenous or diluted medications containing benzyl alcohol. No signs of harm had been seen in administering such products to adults or older children.