Labeling pediatric medicines

Thalidomide would fall into this category due to its inadequate testing but most commonly improper use refers to off-label use. Use of off-label pediatric medicines has been discussed earlier in this chapter. An example of off-label adult use is with Bromfenac (Duract), a nonsteroid anti-inflammatory drug. Duract was developed for short term therapy (<10 days) in 1997 butwith longer term, off-label, use elevated liver enzymes were evident and it was withdrawn approximately 1 year later. In its time on the market Duract generated approximately 90 million dollars in sales. 

The psychiatrist prescribing medications for child and adolescent patients will likely take little comfort in the fact that he or she is no worse off than his or her colleagues in other areas of pediatric medicine. These psychiatrists are faced with the conundrum of either depriving children of potentially effective medication treatment or prescribing such medication off label and without optimal information on dosing, efficacy, and safety in children and adolescents. 

In 1990, the Institute of Medicine sponsored a workshop to address the lack of pediatric labeling. This workshop produced recommendations that eventually led to the pediatric provisions of the FDA Modernization Act (FDAMA) of 1997, as well as to the 1998 FDA Pediatric Rule (FDAMA, 1999). Stimulated by FDAMA and the 1998 Rule, researchers have devel-... 

It may be noted that in anesthetics, pediatrics and intensive care medicine, in particular, drugs are used off-label almost routinely and in practice, it is doubtful that physicians in these specialties are... 

It may be noted that in anesthetics, pediatrics and intensive care medicine in particular, drugs are used off-label almost routinely, and in practice it is doubtful that physicians in these specialties are even aware of these nuances in the IND regulations. Reimbursement systems in the USA will, however, often refuse to pay for drugs used off-label , and use this part of the regulations as their justification. 

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