Off-label Drugs Given to Pediatric Patients: Risky Medicine?


Home / Off-label Drugs Given to Pediatric Patients: Risky Medicine?

Are kids being given drugs without adequate testing? Image by alifarid

The infants and children in the Pediatric Intensive Care Unit (PICU) are the sickest of the sick, and every life-saving strategy is made with the parent’s consent – but do parents understand that some of the drugs given to their children have not been tested for safety in kids?

These medications have the potential to help or even save lives, but their intended purpose is not always for pediatric patients, according to a new study.

Off-Label Drugs in the PICU

The term ‘off-label,’ when applied to medication, refers to a use of a drug in a way that is not included on the approved label.

New research that was presented during the American Academy of Pediatrics National Conference and Exhibition found that doctors ordered off-label medications for 96 percent of pediatric patients in an intensive care unit of an urban hospital.

For this study, off-label drugs were defined as medications that were prescribed to a patient whose age was not listed on the drug packaging, or if the drug was used in a manner for which it had not received FDA approval. Out of the 492 pediatric patients, ages birth through 17, researchers found that 96 percent of them received at least one off-label drug.

Decoded Science had the opportunity to interview Susan Sorenson, Doctor of Pharmacy, about the concerns parents may have and why this is so common. According to Dr. Sorenson, “Off-label drug use is not uncommon or illegal. Treatment with medications off-label is the rule rather than the exception in the PICU.  This practice exposes the patient to medications that may not have been adequately studied in that age range, in the ordered dose, or for the specific indication.  These data point to the continued need for pediatric labeling for commonly used medications.”

Risks of Off-Label Drugs vs. Benefits of Life-Saving Treatment

With the use of off-label medication such a common practice, and the fact that they did not study whether there were any side effects or catastrophic results associated with the use of off-label medications in critically-ill pediatric patients, I asked Dr. Sorenson about the continued use of these drugs. Dr. Sorensen responded, “The problem is, sick patients need drugs and just because the label does not carry pediatric information, will not stop a child who needs the treatment the drug delivers, from getting the drug.  Labels that carry a pediatric indication help the practitioner to have a better understanding of the safety and efficacy of the drug.”

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