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Prescribing Off Label Drugs for Children may Be Hazardous

dolescent 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 d
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