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news.Nearly four out of five hospitalized children receive medications that have been approved only for adults, according to a study of patient records in the US.
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Once the FDA approves a drug for any indicated use, physicians may legally prescribe the drug for different conditions and for patients in other age groups.
Over the past decade, federal regulations providing financial incentives to pharmaceutical companies have helped increase the number of drugs approved for children. However, only a small number of drugs have still been tested for use in children.
Researchers analyzed patient records from 31 major US children's hospitals for the entire year of 2004. At least one drug was used off-label in 79% of children requiring hospitalization. Off-label use accounted for $270 million, some 40%, of the total dollars spent on children's medication in the study.
The drugs most likely to be used off-label in children were those approved for use on the central nervous system or autonomic nervous system, in addition to nutrients and gastrointestinal agents.
The authors point out that while physicians may sometimes have no alternatives to treating children with off-label medications, the practice is not risk-free.
“We hope that by better defining the magnitude of off-label drug use, our study may help encourage greater cooperation among industry, academia and government in carrying out studies to better protect children,” commented Samir Shah, a pediatrician specializing in infectious diseases at The Children’s Hospital of Philadelphia.