Safer Drugs for Kids; September 2012; Scientific American Magazine; by The Editors; 1 Page(s)

Parents assume that when a pediatrician prescribes a drug for their child, that drug has been tested and proven safe and effective. If only it were so. Only half of the medicines doctors prescribe to patients 18 and younger have been through the same rigorous trials as those drugs prescribed to adults. The other half are given off-label—that is, in circumstances for which they were never properly vetted, putting children at risk for overdoses, side effects and long-term health problems. For newborns, that fraction rises to 90 percent. In July the U.S. Congress gave the Food and Drug Administration new authority to compel companies to test their products for kids. The law should improve the situation, but it has worrying gaps.

As biologists have come to appreciate, drug metabolism is one of the many ways in which kids are not just small adults. When doctors downsize an adult dosage to suit a child's weight or body surface area, a drug can prove ineffective or harmful. Infants have immature livers and kidneys, so even a seemingly small dose of medicine can build up quickly in their bodies. As children mature, their organs can develop faster than their body size, so they need to take disproportionately more of the drug. For example, some recent pediatric clinical trials have found that the asthma medication albuterol does not work for children younger than four when taken through an inhaler. The seizure drug gabapentin (Neurontin) requires higher-than-expected doses for children under five.