Unsafe Drugs: Off-Label Drug Use Common in Kids

The largest study to date to look at the use of off-label drug usage in a pediatric setting has found that nearly 80 percent of hospitalized children are given drugs that have been only approved for adults. The researchers who led the study say that the pharmaceutical industry and the Food and Drug Administration need to address the findings, which will appear in the March issue of the Archives of Pediatrics and Adolescent Medicine.

Off-Label Use Common in Kids

Samir Shah, the lead author of the study who also is a pediatrician specializing in infectious diseases at The Children's Hospital of Philadelphia, said that "when almost 80 percent of patients receive a drug off-label, that`s a situation that is unacceptable." The major concern about off-label drug use in children is that the drugs' effects have not been studied in children to fully know if they have adverse effects. The FDA says that it was aware of how widespread off-label drug use is in children and was working to address the issue.