FDA Launches New Pediatric Database

Resource offers useful information for parents, providers
Author: Sarah Aldridge

When it comes to drugs, children are not smaller versions of adults. That’s why rigorous testing of medications need to be performed in pediatric patients to determine each drug’s safety, efficacy and side effects in children. Congress passed the Best Pharmaceuticals for Children Act in 2002 and the Pediatric Research Equity Act in 2003 to increase the number of drug studies in children so that product labels are more informative and accurate. To house the results of those studies, the US Food and Drug Administration (FDA) has launched the Pediatric Labeling Information Database.

This new database, created by the FDA’s Office of Pediatric Therapeutics (OPT) and Center for Biologics Evaluation and Research allows parents and healthcare providers to search for a drug by its chemical name, trade name or by the condition for which it is prescribed. The drugs run the gamut from allergy products to anti-seizure medications, from fibrin sealants used during surgery to products to treat heavy menstrual bleeding.

Expanded studies have led to labeling changes in more than 440 pediatric medications, including 36 drugs with new dosing amounts or dosing changes; 80 drugs that now state they are not effective in children; 84 medications with new or enhanced safety data, which was previously unknown; and 339 drugs with expanded approval to cover a new age group. All of this new information from the studies can be found in the Pediatric Use section of the prescribing information for each medication.

Further, a Safety Reporting page contains a list of products that have generated a so-called “adverse event report” of unwanted side effects. The reports are reviewed by the FDA’s Pediatric Advisory Committee, whose recommendations are given if further actions are needed to ensure product safety. Parents and providers can read the summary of the committee’s meetings and findings. 

In 1975, only 22% of  medications had information on pediatric use. By 2009, that figure jumped to 41%, nearly doubling. A research letter published in the Journal of the American Medical Association (JAMA) in 2012 reported on the findings of investigators at the University of Maryland, Baltimore and the FDA who used the electronic version of the 2009 Physicians’ Desk Reference to review pediatric labeling of current medications. The research study included prescription and some over-the-counter products, and excluded topical treatments and nasal sprays. The researchers discovered that of the 560 drugs they analyzed, 41% were adequately labeled and 5% were partially labeled for use in pediatrics, for a total of 46%. Adequate labeling meant the drug was approved for pediatric use; had been studied in children; or had safety, efficacy or dosing information for all appropriate pediatric populations. Drugs with partial labels were missing information for some of the approved pediatric subpopulations. The investigators concluded that 54% of the drugs lacked appropriate pediatric information.

The researchers also reviewed “new molecular entities,” or ingredients added to drugs. Of the 105 new ingredients approved by the FDA from 2002 to 2008 for potential pediatric use, only 43, or 41%, included pediatric information on the label.

“There is still much work to be done, as we have only studied two-thirds of the products that are al-ready on the market,” says Dianne Murphy, MD, OPT director and study co-author, in a press release. “And there is a steady stream of new products approved every year for children and adults.” To that end, the database will be updated with future research studies that culminate in label changes. Reviews of new drugs will be added as they come to market.