Because medications often react differently in adults and children, parents need to be aware of the risks and benefits of doling out certain drugs to their little ones. And the Food and Drug Administration wants to prepare adults with the information they need to ensure their children are safe.
To that end, they’re promoting the benefits of new legislation passed by Congress that tasks drug manufacturers with increasing the number of drug studies in which children take part. Most products only get studied in adults, hence safe dosing and dangers may not necessarily be accurate in children. Because of the difference in how medicine works across age groups, it’s hoped that the new legislation can help narrow the knowledge gap.
The FDA has also developed a resource known as the Pediatric Labeling Information Database. This critical tool was developed jointly by the organization’s Center for Biologics Evaluation and Research and the Office of Pediatric Therapeutics. Already, the FDA says that the database contains 440 entries on safety information that were the direct result of the passed legislation. Hundreds of instances of labels being changed were based off of the results of pediatric studies.
The Office of Pediatric Therapeutics, in addition to the database described, also has a page dedicated to medical products that pose a threat to children. This page typically lists products that have been the subject of an adverse event report.
All of these things are being shared by the FDA so that consumers know the various resources they can turn to to make sure their children aren’t put at risk.