Animal & Veterinary
Veterinary Adverse Event Voluntary Reporting
How to Report An Adverse Drug Experience
Introduction
Veterinarians and animal owners are encouraged to report adverse experiences and product failures to the government Agency that regulates the product. After the product is marketed, data from the adverse experience reports are used to maintain safety surveillance of these products. For approved products, FDA CVM encourages you to contact the manufacturer of the suspect product.
Reporting information for the following product categories:
- Animal Drugs and Devices
Veterinarians and animal owners may report adverse drug experiences to FDA by:
A. You should first call the drug company to report an ADE for an FDA-approved animal drug. Drug company phone numbers can usually be obtained from product labeling. Inform the drug company that you wish to report an ADE, and ask to speak to a technical services veterinarian. The technical services veterinarian should ask a series of questions about the event, complete the FDA 1932 form, and forward the report to CVM. In addition, the technical services veterinarian may also contact the veterinarian who treated your pet to obtain more information regarding the ADE.
If the drug is not FDA-approved for animal administration, or if it is approved but you do not wish to contact the manufacturer, the report may be submitted directly to the FDA on Form 1932a.
Reports should preferably include a good medical history, all concomitant drugs the animal has been given, any recent surgical procedures, and as much in the way of clinical findings as is possible. Clinical findings would include veterinary exam, clinical chemistries, complete blood counts, urinalysis, fecal exams, radiographic results, and hemodynamic data such as blood pressure, any other pressure measurements in or around the heart, and neurologic assessments.
B. Submitting FORM FDA 1932a, "Veterinary Adverse Experience, Lack of Effectiveness or Product Defect Report". The 1932a is a pre-addressed, prepaid postage form which can be completed and dropped in the mail. This form may be obtained by <clicking> the highlighted title above or by writing to:
ADE Reporting System
Center for Veterinary Medicine
U.S. Food & Drug Administration
7500 Standish Place
Rockville, MD 20855-2773The Center may occasionally need more detailed information about an incident and the reporter may be called by a CVM staff veterinarian.
C. Telephoning the Center for Veterinary Medicine: 1-888-FDA-VETS
IMPORTANT: The identities of all persons and animals is held in strict confidence by FDA and protected to the fullest extent of the law. The reporter's identity may be shared with the manufacturer or distributor unless requested otherwise. However, FDA will not disclose the reporter's identity to a request from the public, pursuant to the Freedom of Information Act.
Leave your name, address, phone number and the brand name of the drug involved. Ask to have a 1932a form sent or ask for the phone number of the drug company you should call to report the problem.
Animal Biologics: Vaccines, Bacterins and Diagnostic Kits
U.S. Department of Agriculture
(800) 752-6255Pesticides: Topically Applied External Parasiticides
U.S. Environmental Protection Agency
(800) 858-PEST
