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Article: Drug research and children: recent studies are providing important new information about drug safety and effectiveness for children. Pediatricians say it's about time.
- Article from:
- FDA Consumer
- Article date:
- January 1, 2003
- Author:
CopyrightCOPYRIGHT 2003 U.S. Government Printing Office. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Most drugs prescribed for children have not been tested in children. Only 20 percent to 30 percent of drugs approved by the Food and Drug Administration are labeled for pediatric use. So by necessity, doctors have routinely given drugs to children "off label," which means the drug hasn't been studied in children in adequate, well-controlled clinical trials approved by the agency.
To be well-controlled, a study should have an adequate number of people and a control group--people who are similar to the group taking the drug being studied, but who are receiving some different type of treatment, such as another drug or an inactive pill (placebo).
Experts say ...