CVM Expands the Cumulative Veterinary Adverse Drug Experience (ADE) Reports

July 12, 2011

The Food and Drug Administration’s Center for Veterinary Medicine (CVM) announced today that, along with the “signs associated with an animal drug” currently reported in its Cumulative ADE Summaries Report, it would now, also, provide the “number of times reported.” CVM is providing these numbers due to the large amount of public interest and in the spirit of openness and transparency.

The Cumulative ADE Summaries Report is an easily accessible database that provides veterinarians and animal owners with access to information about signs associated with the use of animal drugs.

CVM’s primary purpose for maintaining the database is to provide the public with updated adverse events not detected during pre-market testing of FDA-approved animal drugs and for monitoring the performance of unapproved animal drugs.

The public can use the database to search for the active ingredient of a drug to see if particular signs associated with adverse reactions have been reported with the drug’s use. These signs are listed in order from most frequently observed to least frequently observed.

The report cannot be used to estimate drug risk or compare one drug with another.