When adults are advised by their health care professional to use a medication, they expect to receive information—backed up by data from studies—on the correct and safe dose to take. For drugs used in children, this information may not be available because historically not all products are studied in children.
To fix this situation, Congress passed legislation to increase pediatric studies and incorporate the resulting information in labeling. This is a key point because medicines often affect children differently from the way they work in adults.
The Food and Drug Administration (FDA) has been working hard on this project. To make it easier for parents and health care professionals to find information on pediatric medications, the FDA created a database that covers medical products studied in children under recent pediatric legislation.
A Label for Kids
Parents should always read medicine labeling carefully. For prescription medications and vaccines, there is a Pediatric Use section in the labeling that says if the medication has been studied for its effects on children. The labeling will also tell you what ages have been studied. (This labeling is the package insert with details about a prescription medication.)
Congress’ efforts to increase the number of studies of prescription drugs used in children have allowed FDA to build a foundation for pediatric research and discover new things. For example, researchers have found that certain drugs produce more side effects for the nervous system in children than adults, says Dianne Murphy, M.D., OPT’s director.
FDA is able to use information gathered from pediatric studies to make labeling changes specific to kids, and to share that news with the public. The database, which is updated regularly, currently contains more than 440 entries of pediatric information from the studies submitted in response to pediatric legislative initiatives. The labeling changes include:
- 84 drugs with new or enhanced pediatric safety data that hadn’t been known before;
- 36 drugs with new dosing or dosing changes;
- 80 drugs with information stating that they were not found to be effective in children; and
- 339 drugs for which the approved use has been expanded to cover a new age group based on studies.
The easiest way for parents to use the database is to search by their child’s condition to find all mentions of that condition in all of the labeling information within the database. If you know the name of the drug you want to find, sort the database’s information by trade name.
Avant says parents should note that the database contains the version of the label at the time of the labeling change. It may not be updated with later changes if they don’t affect children.