PHILADELPHIA -- Nearly 80% of hospitalized children are medicated with drugs that have not been approved by the FDA for pediatric use, according to a study here.
PHILADELPHIA, March 8 -- Nearly 80% of hospitalized children are medicated with drugs that have not been approved by the FDA for pediatric use, according to a study here.
"Though off-label drug use also occurs in adults, the problem is substantially greater in children because many drugs have not been tested in any pediatric population for any indication," said Samir S. Shah, M.D., of the Children's Hospital of Philadelphia.
Central and autonomic nervous system drugs, such as morphine, were the most common to be given off-label, Dr. Shah and colleagues reported in the March issue of Archives of Pediatric and Adolescent Medicine. Such drugs were given to 66% of the hospitalized children.
The study examined only off-label use by age, not indication, so the results "likely underestimate the magnitude of off-label drug use in children," the investigators said.
They analyzed records from the Pediatric Health Information System database on more than 355,000 children 18 or younger admitted to 31 U.S. hospitals during 2004. The investigators focused on 90 drugs thought to be administered frequently to children or recommended for further study in children by the FDA. Key results include:
The study participants were 55% male, 51% white, 21% black, and 16% Hispanic. But gender and racial differences were not associated with overall off-label drug use, the study found.
More severe illness, as assessed by case mix index (CMI), was also associated with off-label pediatric use. The average CMI for those receiving an off-label drug was 1.83, compared with 0.98 for those who not receiving an off-label drug (P