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Only Half of Meds Taken by Kids Have 'Adequate' Safety Info: Study
Date:5/11/2012

By Jenifer Goodwin
HealthDay Reporter

THURSDAY, May 10 (HealthDay News) -- About half of medications used in children have little or no label information about drug effectiveness, safety or dosing in children, new research finds.

"We still have a long way to go," said senior study author Dr. M. Dianne Murphy, director of the U.S. Food and Drug Administration's Office of Pediatric Therapeutics, although she acknowledged significant strides in pediatric labeling over the past few decades.

In the study, when the researchers looked at 560 medications listed in the 2009 electronic Physicians' Desk Reference, some not relevant for pediatric use, they found only 46 percent referred to children's usage. When they looked only at drugs used in children, they found "adequate" labeling information for 231 of 461 drugs. "Adequate" meant they included information on drug effectiveness, safety in kids and teens, and guidance on dosing.

Among medical professionals, there's a growing understanding that children aren't mini-adults. They may metabolize drugs differently, their bodies may react to drugs differently, and diseases themselves may have different causes or underlying mechanisms in kids than adults.

Dr. Daniel Frattarelli, a pediatrician in Dearborn, Mich., and chair of the American Academy of Pediatrics Drug Committee, said the numbers represent a big improvement over recent history. But 90 percent of medications used to treat newborns still have not been adequately studied, he said.

"We still have a huge problem with newborns," he said.

"It's great that we've made all of this progress in older children, but for babies, they're very vulnerable, they're often in the neonatal ICU [intensive care unit], and their metabolism is different even than for older children," Frattarelli said.

In 1975, the last time a similar study of drug labels was conducted, only 22 percent of medications had informa
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