Adverse Drug Experience (ADE) Reports

ADE Report Description How to Use These Reports Additional Information Disclaimer

Cumulative Veterinary ADE Reports 1987 to September 30, 2012 A-C - ADE Summaries (accessible version) D-I - ADE Summaries (accessible version)  J-M - ADE Summaries (accessible version)  N-S - ADE Summaries (accessible version)  T-Z - ADE Summaries (accessible version)

In the spirit of openness and transparency, the Center for Veterinary Medicine (CVM) has created and posted these ADE summary reports for the public. CVM has posted the Cumulative ADE Summaries Report so that veterinarians and animal owners can have easily available access to information about signs that have been associated with drugs. These reports will be updated on a monthly basis. This summary report does not include electronic submissions. We are currently developing this capability and will include electronic submissions at some point in the future.

ADE Report Description

The primary purpose for maintaining the CVM ADE database is to provide an early warning or signaling system to CVM 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 is 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 Center's adverse drug experience (ADE) process takes into consideration confounding factors such as:

• Dosage
• Concomitant drug use
• The medical and physical condition of animals at the time of treatment
• Environmental and management information
• Product defects
• Extra-label-uses

However, the specifics of these complex factors cannot be addressed in these reports.

The CVM ADE reporting system depends on detection of adverse clinical events by veterinarians and animal owners. For information on ADE reporting, see Veterinary Adverse Event Voluntary Reporting. For information on how CVM reviews an ADE, see Data Analysis for Adverse Drug Events Reported to CVM.

How to Use These Reports

Search for the active ingredient of a drug to see if particular signs have been reported with its use. These signs are listed in order from most frequently observed to least frequently observed. (Glossary of ADE Terms)  It is important to remember that the report cannot be used to estimate drug risk or compare one drug with another. 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. Accumulated ADE reports should not be used to calculate incidence rates or estimates of drug risk, because there is no accurate way to determine how many animals were given the drug. For example, if a drug is widely used to treat certain conditions, there may be more ADEs for that drug than another product that is not used as often. This would not mean that the first drug was more unsafe than the second. The number of reports simply represents the numbers of ADEs received for a particular drug, by species, and route of administration.
4. Information on how the drugs were used (for indications on the product label or in an extra label manner) is not provided.
5. Adverse experiences are listed by the active ingredient of each drug in the ADE Report. One of the active ingredients 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 Animal Drugs @ FDA and selecting Section 2: Active Ingredients.

Additional Information

For additional information about the review and evaluation of adverse event reports, see the following documents:   

• VICH GL24 - Management of Adverse Event Reports (AER's)
• VICH GL30 - Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms
• VICH GL42 - Pharmacovigilance of Veterinary Medicinal Products: Data Elements for Submission of Adverse Event Reports 

Disclaimer

Any reference to a commercial product, process, service, or company is not an endorsement or recommendation by the U.S. government, the Department of Health and Human Services, FDA or any of its components. FDA is not responsible for the contents of any off-site Internet information referenced by or linked to the agency's internet site.

The information provided using this Internet page is only intended to be General Summary Information to the Public. It is not intended to take the place of either the written law or regulations. For an authoritative source, the FDA Regulations are published in the Code of Federal Regulations (CFR), and are available in book format from the Superintendent of Documents, U.S. Government Printing Office. The CFR is also available online at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm.