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Many children treated at pediatric hospitals receive at least one "off-label" medication

Many medications prescribed for children have not been formally studied in children and most are not labeled for use in children. However, a new study indicates that many children treated at pediatric hospitals receive at least one medication "off-label" or not approved by the Food and Drug Administration (FDA) for their age.

The researchers examined use of 90 drugs among children treated at 31 major children's hospitals across the United States. At least one of the drugs was used off-label in over three-fourths (78.7 percent) of children discharged from pediatric hospitals during the study. Over a 1-year period, off-label use of the 90 drugs in the study accounted for more than $250 million and 2.3 percent of total inpatient charges.

The frequency of off-label drug use varied within drug classes and diagnostic categories. For example, while some commonly used analgesic medications were rarely used off-label (for example, acetaminophen), other analgesics were almost always used off-label. For example, morphine was used in nearly 28 percent of children discharged. Because there is no FDA indication for morphine administration in children, however, its use was considered off-label in 96.7 percent of these patients.

In every diagnostic category, at least one drug was used off-label in more than half of patients, and occurred disproportionately in patients receiving central and autonomic nervous system agents. In all procedural or surgical categories, at least one drug was used off-label in more than 90 percent of patients, especially drugs affecting the central and autonomic nervous system, fluids or nutrients, and drugs affecting the gastrointestinal tract.

Patients who were more severely ill and had longer hospital stays (6.68 vs. 2.79 days) were more likely to receive off-label drugs than other patients, as were patients who were older than 28 days, underwent a surgical procedure, or died in the hospital. The researchers defined off-label drug use based solely on age criteria.

Use of the medications for reasons other than those stated on the product label also constitutes off-label use, but was not studied. The study was supported by the Agency for Healthcare Research and Quality (HS14009).

More details are in "Off-label drug use in hospitalized children," by Samir S. Shah, M.D., Matthew Hall, Ph.D., Denise M. Goodman, M.D., M.S., and others, in the March 2007 Archives of Pediatric and Adolescent Medicine 161, pp. 282-290.

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