Animal & Veterinary

ADE Frequently Asked Questions

What is included in the veterinary ADE database?

What is not included in the ADE reporting system?

Veterinary ADEs are not:

  • Complaints regarding human drugs unless administered to animals

    • MedWatch maintains the FDA Safety Information and Adverse Event Reporting Program for human drugs administered to humans
  • Accepted via e-mail
  • For animal biologics or vaccines

  • For topical insecticides.

  • Complaints regarding veterinary standard of care issues.

  • Complaints regarding company or veterinary reimbursement of costs associated with a pet’s illness.

Can my veterinarian prescribe a human drug for my dog?

The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) allows veterinarians to prescribe extralabel uses of certain approved animal drugs and approved human drugs for animals under certain conditions. Extralabel (or extra-label or off label) use refers to the use of an approved drug in a manner that is not in accordance with the approved label directions. The key constraints of AMDUCA are that any extralabel use must be by, or on the order of, a veterinarian within the context of a veterinarian-client-patient relationship, must not result in violative residues in food-producing animals, and the use must be in conformance with the implementing regulations published at 21 CFR Part 530.

What kind of information should be included in my complaint?

It is most helpful if the report includes includes a good medical history, all concomitant drugs the animal has been given and if available:

  • veterinary exam results,
  • clinical chemistries,
  • complete blood counts,
  • urinalysis,
  • fecal exams,
  • radiographic results,
  • hemodynamic data such as blood pressure, any other pressure measurements in or around the heart,
  • neurologic assessments,
  • and any recent surgical history.

 

Page Last Updated: 10/16/2014
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