FDA Publishes Adverse Drug Experience Reports

September 12, 2006 — 

The U.S. Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM) has published the cumulative Adverse Drug Experience (ADE) reports from 1987 to current in an easily accessible format to provide veterinarians and animal owners access to information regarding adverse drug reactions.

Drugs are listed by their active ingredients and the adverse signs for each drug are listed in order of the frequency observed. One active ingredient in the list may represent more than one brand name. Interested individuals can find a complete list of brand names associated with each active ingredient by using the on-line "Green Book" .

The primary purpose for maintaining the FDA/Center for Veterinary Medicine Adverse Drug Experiences (ADE) database is to provide an early warning or signaling system to the Center for adverse effects not detected during pre-market testing of FDA-approved animal drugs and for monitoring the performance of drugs not approved for use in animals.

Information from these ADE reports are coded and entered into a computerized FDA/CVM ADE database. CVM scientists use the ADE database to make decisions about product safety which may include changes to the label or other regulatory action.

The ADE reporting system depends on detection of adverse clinical events by veterinarians and animal owners, associating the clinical event to the use of a particular drug, and reporting of the ADE to the manufacturer of the drug or directly to FDA. Reporting of ADEs by veterinarians and animal owners is voluntary.