FDA creates pediatric medicine database

June 7, 2012

The US Food and Drug Administration (FDA) has released a new database of pediatric medications to assist health care professionals find information on medical products studied in children. How will this resource clarify the prescribing of medicines?

The US Food and Drug Administration (FDA) has released a new database of pediatric medications to assist health care professionals find information on medical products studied in children.

The project complies with recent pediatric legislative initiatives that call for increasing studies of drugs in children and incorporating more information about medication effects on children into product labeling.

The new Pediatric Labeling Information Database is searchable by the product’s trade name or generic name, by the specific disease or condition, labeling change summaries, and by therapeutic categories. Health care professionals can locate current information on correct dosing and the effects of certain medicines.

In addition, FDA maintains a safety reporting page that offers up-to-date information on pediatric drugs that have been associated with adverse event reports and what actions have been taken to ensure safe use of products in children.

Products listed in the database fall within the scope of studies performed under the Pediatric Rule, the Best Pharmaceuticals for Children Act, and the Pediatric Research Equity Act.

Go back to the current issue of the eConsult.