Study finds safety test results on children's drugs not always reaching ...( h the pediatric exclusivity program and...),Health

In another study, the drug Propofol, while effective when used to induce or maintain anesthesia in critically ill patients, proved to have an increased mortality rate among pediatric patients when used as a sedative, compared with patients who received standard sedative agents. As a result of this study, a labeling change was made.

The researchers found that if a study resulted in a "positive" labeling change, meaning a drug's safety and effectiveness in children was established, it was more likely to be published. Fifty-four percent of such studies were published, compared with 36 percent of studies that resulted in a negative labeling change, which might include a finding that the drug showed no meaningful clinical effect in children or that it was associated with a worse outcome than the comparison therapy.

Though the pediatric exclusivity program itself has been a useful tool in making drugs safer for children through labeling changes, more can be done to make sure this information is getting into the right hands, said Benjamin.

"Physicians are used to using peer-reviewed journals as a source for the latest medical information, so it makes sense to get this information in there," he said.

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Contact: Lauren Shaftel
lauren.shaftel@duke.edu
919-684-4966
Duke University Medical Center
12-Sep-2006