The team reports its findings in the Sept. 13, 2006 issue of the Journal of the American Medical Association. There was no grant funding for this study.
Between 1998 and 2004, manufacturers conducted 253 studies through the pediatric exclusivity program on drugs indicated for the treatment of conditions such as pain, diabetes, gastroesophageal reflux, seizures and psychiatric disorders, among others. According to Benjamin, the studies resulted in key labeling changes -- defined as a significant finding related to dosing, safety or efficacy that is different from adults -- on 100 drugs. But of those studies, only 37 were published in peer-reviewed journals, the researchers found.
Studies could result in more than one key labeling change. In cases where there was a dosing change, only 49 percent of studies were published in peer-reviewed journals. When there was a change to safety information, only 43 percent were published, and when the drug was found to be ineffective in children, only 38 percent were published, the study found.
The FDA publishes label change information on its Web site (http://www.fda.gov/cder/pediatric/labelchange.htm), but users must know what they are looking for and where to look in order to find it, Benjamin said.
"The pediatric exclusivity program has been extremely successful in bringing about labeling changes where indicated, but additional efforts are needed to better inform the medical community about these changes and the studies behind them," he said. "Not having this information can be detrimental to patient care."
Examples of drugs that were tested throug
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Contact: Lauren Shaftel
lauren.shaftel@duke.edu
919-684-4966
Duke University Medical Center
12-Sep-2006