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Center for Veterinary Medicine
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ADE Report Description

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 FDA/Center for Veterinary Medicine (CVM) 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. 

In the spirit of openness and transparency, CVM has created and posted this ADE summary report for the public. The appropriate use of this website information is to search the active ingredient of a drug to see if particular signs have been reported with their use. These signs are listed in order of frequency from most frequently observed to least frequently observed.

When looking at the report, the reader should be aware that:

  1. For any given ADE report, there is no certainty that the reported drug caused the adverse event.  The adverse event may have been related to an underlying disease, using other drugs at the same time, or other non-drug related causes.  And, this listing does not include information about underlying diseases, other drugs used at the same time, other non-drug related causes, or the final outcome of the reaction.

  2. The accuracy of information regarding the ADE is dependent on the quality of information received from the veterinarian or animal owner.

  3. Information on how the drugs were used (for indications on the product label or in an extra label manner) is not provided.

  4. Adverse experiences are listed by the active ingredient of each drug in the ADE Report. One the 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” and clicking on the following link - List of Brand Names Associated with Active Ingredients.

Data Collection

Reporting of ADEs by veterinarians and animal owners is voluntary. Reports may be sent directly to the FDA/CVM ("Direct" reports), to the drug manufacturer ("Manufacturer" reports), or to both.  This is a link to information on how to report an ADE -  Data Analysis for Adverse Drug Events Reported to CVM.

Classification of the clinical sign (ADE)

Veterinarians in the Division of Surveillance analyze the data on signs provided to classify the clinical sign as remotely drug related, or as possibly, probably, or definitely related to the drug. 

Additional Information

Additional information on the criteria and responsibilities for the consolidation, screening, review, and evaluation of drug experience reports is further detailed in the CVM Program Policy and Procedures Manual section 1240.3522, Review and Evaluation of Drug Experience Reports. (1240.3522)

Web Page Updated by hd - November 26, 2007, 11:05 AM ET

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