Failures of initial pediatric monitoring

The Food and Drug Administration Modernization Act, designed to stimulate more drug safety studies in children, has resulted in more than 130 label changes since its inception nearly six years ago, according to researchers at the USA's Duke Children's Hospital.

In their analysis, which appears in the September issue of Pediatrics, the researchers suggest that pediatric post-marketing surveillance is crucial, and that health care providers should take the job of reporting adverse effects seriously as very rare, adverse events are seldom defined during a study of a few hundred children. Learning about these AEs is often dependent on their being reported by health professionals and parents, they noted.

Using MedWatch, the FDA's computerized information database for collecting reports of adverse events, the FDA's Pediatric Advisory Committee reviewed 67 drugs granted the extension. The majority of those studied (65.7%) did not appear to cause enough AEs to require continued pediatric monitoring. However, nearly one in five of the studied drugs required label changes after complications emerged later.