Animal & Veterinary
ADE Frequently Asked Questions
What is included in the veterinary ADE database?
- To see if a drug is approved for animals please search the FDA Approved Animal Drug Products Database
- Some, but not all topical flea products are included. If the product is delivered systemically (goes beyond the skin and is distributed throughout the body), FDA regulates it. Otherwise it is regulated by EPA.
- To report an adverse drug event:
- Veterinary Adverse Event Voluntary Reporting (for Veterinarians and animal owners)
- Veterinary Adverse Event Reporting for Manufacturers
What is not included in the ADE reporting system?
Veterinary ADE’s 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
- Information on how to report animal vaccine adverse events can be found at the USDA Center for Veterinary Biologics
For topical insecticides.
- Complaints regarding non-systemic flea products should be referred to the Environmental Protection Agency hotline at: 1-800-858-7378.
Complaints regarding veterinary standard of care issues.
- Complaints and questions about standard of care issues should be referred to your State Veterinary Medical Board. See the American Association of Veterinary State Boards (AAVSB) and/or the National Board of Veterinary Medical Examiners (NBVME)
- 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,
- 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.
Animal Drugs @ FDA American Association of Veterinary State Boards (AAVSB) National Board of Veterinary Medical Examiners (NBVME) Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) MedWatch: The FDA Safety Information and Adverse Event Reporting Program Medical Product Safety Information Center for Veterinary Biologics Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect (PDF)(PDF - 809KB)