Meds Often Given Off-Label to Kids

Intensive care patients are often given drugs off label because research is lacking

/ Author:  / Reviewed by: Robert Carlson, M.D

(RxWiki News) Doctors often have to make choices about medications for children based on information about adults. Research about drugs for children is limited.

A recent study found that kids in the hospital are often given drugs that are not approved for use. Some of the most commonly used off-label medications were morphine, fentanyl, and lorazepam.

These medications may put children at risk because the best doses and medication types for children may be different from adults.

"Ask about your child’s medications."

Susan Sorenson, PharmD, of the Primary Children's Medical Center in Salt Lake City, Utah, led a presentation at the American Academy of Pediatrics National Conference.

They presented the results of a study that looked at children admitted to a pediatric intensive care unit (PICU) over one year at the Primary Children’s Medical Center.

The looked at the types of drugs children were prescribed and whether or not the drugs prescribed were for off-label uses.

Off-label drug use was considered to be any use where the pediatric patients had not been approved by the U.S. Food and Drug Administration (FDA) or where the drug was used to treat a condition not approved by the FDA.

There were 490 patients in the study between the ages of 4 days to 17 years.

Off-label use was seen in 96 percent of patients overall.  When they looked at specific age ranges, 100% of children between the ages of 13- and 17-years-old took an off-label medication.

The authors concluded, “Treatment with medications off-label is the rule rather than the exception in the PICU.”

In a recent press release, the lead author said that this study highlights the problems doctors have with pediatric patients. They want to treat the patient, but there is not enough research about the best way to use medications in children.

She also said that she hoped this study would lead to more research so that doctors can have better information about safe use of medication in children.

Drug companies rarely seek FDA approval because the extra trials needed are expensive. Doctors can choose to use the medications off-label for children.

However, this gives doctors little information about the best and safest dose for a drug when used in children.

These study results were presented at the American Academy of Pediatrics National Conference on October 21.

Because these results were presented at conference, they may not have been reviewed by experts in the field for scientific rigor and accuracy.

Reviewed by: 
Review Date: 
October 21, 2012
Last Updated:
October 23, 2012