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Adverse Drug Experience Reporting

Veterinary Adverse Drug Experience (ADE) 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.

These reports include all domestic adverse drug experience reports submitted to the Center for Veterinary Medicine (CVM or the Center) that the Center have been determined to be at least "possibly" drug related. 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

NOTE: These reports are intended ONLY as a general reference to the type of adverse experience that veterinarians, animal owners, and others have voluntarily reported either to the FDA or to the manufacturer as associated with drug use. These reports should NOT be used for:

  • Determining drug association for a particular sign

  • Determining the safety and efficacy of a given drug

  • Determining the frequency of occurrence of an adverse experience

  • Determining the effects of on-label versus extra-label use of a drug

  • Comparing one drug with another drug

Updated Friday, July 16, 2004 at 3:56 PM ET - swd

 

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