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Database Is One-Stop Resource on Kids' Medications

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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.

More Than Halfway There

OPT has also evaluated the amount of progress in the inclusion of pediatric information in drug labeling and has published a research letter in the Journal of the American Medical Association67on May 9, 2012. They found that in 2009, more than 60% percent of the drugs used for both adults and children that were in the Physician's Desk Reference—a drug information resource for physicians and other health professionals—had specific information on pediatric use, compared to only 22 percent in 1975.

Critical information in the pediatric section of the labeling tells you if the product was studied in children but could not be shown to work. When a product has been studied in adults and cannot be shown to be effective, that information is not put in the label. However, Congress told FDA to put this information in labeling when a product had been studied in children and was not effective.

“There is still much work to be done, as we have only studied two thirds of the products that are already on the market,” says Murphy. “And there is a steady stream of new products approved every year for children and adults.”

For more information about topics for your health, visit the FDA Consumer Information Center (http://www.fda.gov/ForConsumers/default.htm).   

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