December 20, 2005 -- FDA Cites Progress in Labeling Pediatric Drugs

One hundred of the drugs most often prescribed for children and adolescents now carry information on their labels about safety, efficacy, and risks for children and the appropriate dosages for various age levels, the U.S. Food and Drug Administration (FDA) announced December 19. Sparked by federal laws that give drug companies extended copyright protection if they conduct research in children on drugs expected to be prescribed for children, there has been a surge in pediatric studies in recent years, the FDA noted as it announced that Trileptal, a drug used to treat seizures, is the 100th medication to include safety, efficacy, risks, and dosing information on its labels. Among more than 250 pediatric studies that have been conducted since the first federal law was enacted in 1997 have been drugs prescribed for a wide range of childhood conditions, including asthma, HIV, seizures, juvenile rheumatoid arthritis, pain management, diabetes, high blood pressure, attention deficit hyperactivity disorder, brain tumors, and leukemia, said Steven Galson, director of the FDA’s Center for Drug Evaluation and Research. A list of the 100 drugs that currently carry pediatric labeling is available at www.fda.gov/cder/pediatric/labelchange.htm