FDA calls on parents to report medical side effects
The Food and Drug Administration is asking parents to help the agency confirm children's medical products are really safe.
Reporting to FDA such "adverse events" as unexpected, serious side effects, accidental exposure, and product quality issues can prompt the agency to act—and it can also bring new pediatric safety information to light.
Reports submitted to FDA make a difference, says Dianne Murphy, M.D., director of FDA's Office of Pediatric Therapeutics, which focuses on safety, scientific and ethical issues that arise in pediatric clinical trials (tests of new medical products that are required before the products may be approved) or after products are approved for use in children.
"Even a single well-documented report can lead to additional research and analysis that might result in a label change or other FDA action," she said.
"Most pediatric clinical trials involve a relatively small number of patients," says Murphy, and problems might not be detected until the products are in widespread use.
A drug or device might be studied in one pediatric age group, but prescribed and used in another age group in which it has not been studied, she says.
"Of the millions of adverse event reports submitted to FDA, only a small percent are for children," says Jo Wyeth, Pharm.D., a safety evaluator with FDA's Office of Surveillance and Epidemiology, an office that tracks such reports.
In 2012, FDA received nearly 900,000 adverse event and medication error reports, but only 5 percent were associated with children under 18 years of age.