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Majority of Drugs Prescribed for Children Have Not Been Approved for Pediatric Use

Oct 20, 2014

Less than half of the drugs prescribed for children — 46 percent — are approved for use in child patients. But clinical trials rarely include children, leaving most decisions about medications and doses to doctors.

In the absence of federal approval for drugs for children, doctors must use other means to make prescribing decisions, including peer-reviewed literature and hospitals’ patient experiences, Scientific American reports. Expert committees at hospitals deliberate usage. But such approaches do not equal the scrutiny involved when the Food and Drug Administration (FDA) approves a drug for a specific use. Most pediatric pharmaceutical prescribing relies on off-label approaches and in neonatal intensive care units, 90 percent of drugs are used off-label.

After a medication receives FDA approval, doctors may prescribe it for any purpose they consider medically appropriate. Off-label use of drugs is often the only option in pediatrics but this can lead to problems, because, as Scientific American explains, children are not just tiny adults. Reducing the dosage prescribed for an adult to a proportional level for a child does not insure the drug will work the same way. Extrapolating dosage by weight can have adverse consequences for child patients. Bactrim, for example, a popular antibiotic for adults, can result in jaundice and brain damage in newborns because their livers are not able to metabolize the drug.

There are many obstacles to getting better clinical trial data for children. Because pharmaceutical companies know that drugs will be used off-label in children anyway, companies do not have financial incentives to develop expensive and time-consuming trials, according to Scientific American. Devising appropriate protocols and getting consent for children to participate in trials can be difficult. And children cannot participate in trials on their own; they need adults to transport them.

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