Animal & Veterinary

Tips on Reporting ADEs

Veterinarians and animal owners are encouraged to report adverse drug experiences (ADEs) and suspected product failures to the government Agency that regulates the product. Pre-testing by the manufacturer and review of the data by the government does not guarantee absolute safety and effectiveness of approved veterinary drugs due to the inherent limitations imposed by testing the product on a limited population of animals. Anyone with information to report is also encouraged to contact the manufacturer of the suspect product.

Tips on reporting ADEs

To help FDA’s Center for Veterinary Medicine (CVM) accurately analyze the report, it is important that the reports include complete and accurate clinical information about an animal.

This means that the report should preferably include

  • a good medical history,
  • all other drugs the animal has been given at the same time,
  • pre-existing conditions,
  • any recent surgical procedures,
  • and as much in the way of clinical findings as is possible. Clinical findings include physical exam findings, results of laboratory testing performed (blood work, urinalysis, fecal exams), radiographic (X-ray) results, and any other clinical data such as blood pressure measurements.
Questions regarding ADE Reporting should be addressed to:

Center for Veterinary Medicine
Division of Veterinary Product Safety, HFV-240
7519 Standish Place
Rockville, MD 20855

Page Last Updated: 06/19/2014
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