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Most Children in U.S. Hospitals Receive Medicine Off-Label
Little Is Known of Drugs' Safety and Effectiveness in Children
PHILADELPHIA, March 5 /PRNewswire-USNewswire/ -- Nearly four out of five
hospitalized children receive medications that have been tested and approved
only for adults, according to a study of hundreds of thousands of patient
records. This so-called "off-label" use of drugs was thought to be especially
common in children, and the new research, the largest-ever U.S. pediatric study,
"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
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 Adolescent Medicine.
Off-label prescribing is relatively common among adult patients as well, but it
has long been recognized that a large proportion of drugs used in pediatrics
have never been tested in children. Over the past decade, federal regulations
providing financial incentives to pharmaceutical companies have helped increase
the number of drugs tested and approved for children. However, said Dr. Shah,
"there was little information on the extent of off-label use among children, the
types of drugs used off-label, and the characteristics of hospitalized children
receiving those drugs."
All previous studies of off-label drug use in hospitalized children were
performed outside the United States, often limited to specific conditions or to
patients in single medical centers. This current study focused on 90 drugs that
were either administered frequently to children or were recommended for further
pediatric study by the FDA.
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. For instance, 28 percent of the patients
in the database received morphine, although the FDA has not approved it for use
in children. Anti-cancer drugs were the least likely to be used off-label,
possibly because such drugs are more likely to have been tested in pediatric
cancer patients, who frequently participate in clinical trials.
Children were more likely to receive drugs off-label if they underwent surgery,
were older than 28 days and had more severe illnesses. "Critically ill children
may have failed to respond to conventional therapies and may receive drugs
off-label because they have no approved options," said Dr. Shah.
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.
"Using drugs that have been insufficiently studied in children has contributed
to adverse outcomes, which have been documented in the medical literature," said
Dr. Shah. "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."
In addition to his position at The Children's Hospital of Philadelphia, Dr. Shah
is a Senior Scholar at the Center for Clinical Epidemiology and Biostatistics at
the University of Pennsylvania School of Medicine. Dr. Shah and Dr. Slonim's
co-authors, from several other universities and medical centers, were Matthew
Hall, Ph.D.; Denise M. Goodman, M.D., M.S.; Pamela Feuer, M.D.; Vidya Sharma,
M.B.B.S., M.P.H.; Crayton Fargason, Jr., M.D.; Daniel Hyman, M.D., M.M.M.; Kathy
Jenkins, M.D., M.P.H.; Marjorie L. White, M.D.; Fiona H. Levy, M.D.; James E.
Levin, M.D., Ph.D.; and David Bertoch, M.H.A.
About The Children's Hospital of Philadelphia: The Children's Hospital of
Philadelphia was founded in 1855 as the nation's first pediatric hospital.
Through its long-standing commitment to providing exceptional patient care,
training new generations of pediatric healthcare professionals and pioneering
major research initiatives, Children's Hospital has fostered many discoveries
that have benefited children worldwide. Its pediatric research program is among
the largest in the country, ranking third in National Institutes of Health
funding. In addition, its unique family-centered care and public service
programs have brought the 430-bed hospital recognition as a leading advocate for
children and adolescents. For more information, visit
About Children's National Medical Center: Children's National Medical Center,
located in Washington, D.C., is a proven leader in the development of innovative
new treatments for childhood illness and injury. Consistently ranked among the
top pediatric hospitals in America, Children's has been serving the nation's
children for more than 130 years. Children's Research Institute, the academic
arm of Children's National Medical Center, encompasses the translational,
clinical and community research efforts of the institution. For more information
about Children's National Medical Center, visit