FDA expands adverse drug reports

Aug 18, 2011
By dvm360.com staff
Rockville, Md. — The U.S. Food and Drug Administration (FDA) is adding a new component to adverse drug experience reports, now requiring the frequency of reactions to be added.

Previously FDA’s Center for Veterinary Medicine only included the signs associated with adverse reactions in the Cumulative ADE Summary Reports. Now, in response to increased interest from the public, the agency will list the number of times certain reactions were reported.

ADE reports are accessible through a database on FDA’s website, and offer veterinarians and animal owners information about possible reactions associated with active ingredients used in animal drugs. The main goal of the database, according to FDA is to identify reactions not detected during pre-market testing of FDA-approved animal drugs, and for monitoring the performance of unapproved drugs.

The agency will now list signs associated with adverse reactions from most to least frequent, says FDA.