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Medications used in newborns especially under-studied, doctor says. By Jenifer Goodwin HealthDay Reporter THURSDAY, May 10 (HealthDay News) -- About half of medications usedin children have little or no label information about drugeffectiveness, 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'sOffice of Pediatric Therapeutics, although she acknowledgedsignificant strides in pediatric labeling over the past fewdecades. In the study, when the researchers looked at 560 medications listedin the 2009 electronic Physicians' Desk Reference, some notrelevant for pediatric use, they found only 46 percent referred tochildren'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 thatchildren aren't mini-adults. They may metabolize drugs differently,their bodies may react to drugs differently, and diseasesthemselves may have different causes or underlying mechanisms inkids than adults. Dr. Daniel Frattarelli, a pediatrician in Dearborn, Mich., andchair of the American Academy of Pediatrics Drug Committee, saidthe numbers represent a big improvement over recent history. But 90percent of medications used to treat newborns still have not beenadequately 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 theneonatal ICU [intensive care unit], and their metabolism isdifferent even than for older children," Frattarelli said. In 1975, the last time a similar study of drug labels wasconducted, only 22 percent of medications had information about usein children, Murphy said. Experts at that time wrote "we have to stop treating children likesecond-class citizens and basically experimenting on them becausewe haven't studied these products adequately," said Murphy. Pediatric information on many drugs is limited largely because drugmakers don't often study drugs in children. Ethical issues are onedeterrent, Murphy said. Financial concerns are another. Kidstypically make up a small sliver of the population that will betaking the drugs, so developing and testing drugs for use inchildren "isn't a good business model," she said. Frattarelli credits two laws with boosting pediatric drug testing.The Best Pharmaceuticals for Children Act, enacted in 1997,provides financial incentives to drug makers that conduct clinicaltrials in children when new drugs come to market, and the 2003Pediatric Research Equity Act requires pharmaceutical companies toassess the safety and effectiveness of certain drugs in kids. Since the laws were enacted, more than 400 drug labels have beenaltered to reflect a better understanding of whether the drugs workin kids and the correct dose for them, Murphy said. Still, obstacles remain, such as high drug development costs and afailure of many drugs to make it to market. For these reasons, KateConnors, director of communications for Pharmaceutical Research& Manufacturers of America, an industry association, said drugmakers may not want to take on the expense of conducting trials inchildren. "We are highly supportive of these programs, which have helped toincentivize significant increases in pediatric research," Connorssaid. "There are many reasons why research in pediatric patientshas not been widely available. For one, the cost of developing anew drug is already incredibly high, now exceeding $1 billion, andpediatric trials would add to this cost. So for a medicine that maynot be anticipated for use in children, it may not be worthwhile toconduct pediatric studies." The study authors, writing in the May 9 issue of the Journal of the American Medical Association , said additional legislation is needed to increase pediatricclinical trials and improve labeling. Current legislation comes upfor reauthorization this year, and the American Academy ofPediatrics is requesting that the laws regarding drug-testing innewborns be strengthened, Frattarelli said. More information The U.S. Food and Drug Administration has more on the study of drugs in children . SOURCES: M. Dianne Murphy, M.D., director, Office of PediatricTherapeutics, U.S. Food and Drug Administration; DanielFrattarelli, M.D., pediatrician, Dearborn, Mich., and chair,American Academy of Pediatrics' Drug Committee; Kate Connors,director, communications, Pharmaceutical Research &Manufacturers of America; May 9, 2012, Journal of the American Medical Association Copyright © 2012 HealthDay . All rights reserved. I am an expert from hydraulic-gearpumps.com, while we provides the quality product, such as Hydraulic Steering Units , Directional Hydraulic Valve, Tandem Hydraulic Pump,and more.
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