Parents should have the most up-to-date information on safe dosages regarding medicine for their children. Unfortunately, this information is not always readily available because, historically, not all products are studied in children. This is key because drugs work differently in children from how they work in adults. To remedy this problem, Congress passed legislation to increase the number of pediatric studies and provide the results on the safety labels of medication.

As part of this effort, the Food and Drug Administration (FDA) has created a database that covers medical products studied in children. The Pediatric Labeling Information Database is a one-step resource where parents and health care professionals can find information on pediatric medicines. The database allows users to search the drug’s commercial or chemical name, or by the condition for which it was studied.

The database was a collaborated effort between the FDA’s Center for Drug Evaluation and Research, and the agency’s Office of Pediatric Therapeutics (OPT), which also maintains a Safety Reporting Page with information on products that have been linked to safety problems or side effects that specifically relate to children.

The 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 has 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 database can be found at http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=labelingdatabase

Source: FDA

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