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Prescribing Off Label Drugs for Children may Be Hazardous

A recent pediatric study finds that nearly four out of five hospitalized children receive medications that have been tested and approved only for adults//. The authors fear that treating children with off-label medications can have adverse outcomes.

"We measured the magnitude of off-label use of drugs in children," said study leader Samir S. Shah, M.D., a pediatrician specializing in infectious diseases at The Children’s Hospital of Philadelphia. "Given the nature of the available data, we could not evaluate safety and effectiveness of those medications, although those are important concerns. However, only a small number of drugs have been formally tested in children."

Once the U.S. Food and Drug Administration (FDA) approves a drug for any indicated use, physicians may legally prescribe the drug for different conditions and for patients in other age groups. This study measured off-label use only as defined by age, not by indicated conditions.

"With nearly 80 percent of children receiving off-label medications during hospitalizations, we need to focus our attention on the process by which medications are approved for pediatrics," said senior author Anthony D. Slonim, M.D., Dr.P.H., Executive Director of the Center for Clinical Effectiveness at Children’s National Medical Center. "It is imperative that we thoroughly review this process to ensure that children are being treated with the safest, most effective therapies."

Researchers in the Pediatric Health Information Systems Research Group, representing various medical centers, analyzed patient records from 31 major U.S. children’s hospitals for the entire year of 2004. At least one drug was used off-label in 79 percent of the more than 355,000 children requiring hospitalization. Off-label use accounted for $270 million, some 40 percent, of the total dollars spent on children’s medication in the study, which appears in the March issue of the Archives of Pediatrics and A
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