Adverse events are undesirable animal health occurrences during or after the use of a product or device, and such may or may not be caused by the product or device. Adverse events are rare and the majority of them are minor, but some can be life-threatening.
If you suspect that one of your animals is experiencing an adverse event, call your veterinarian or local veterinary emergency clinic immediately. Addressing your animal’s health needs is the highest priority; reporting the adverse event can be done afterwards.
Where to Report
- All products or devices – report the problem to the manufacture, the contact information for which is likely on the label or other packaging of the product or device. Manufacturers are required to report adverse events to the oversight agency.
- Animal foods and FDA-approved products, such as animal medications and devices –report the adverse event to the FDA online or by calling 1-888-FDA-VETS (1-888-332-8387).
- USDA-approved products, such as animal vaccines – report the adverse event to the USDA APHIS Center for Veterinary Biologics online or by calling 800-752-6255.
- EPA-approved products, such as certain flea and tick products and other pesticides – report the adverse event to the National Pesticide Information Center online or by calling 800-858-7378.
- Consult with your veterinarian about the possible adverse events associated with the product or device being used and contact your veterinarian or local veterinary emergency clinic immediately if you observe any signs of an adverse event.
- Your veterinarian may report the adverse event to the appropriate agency and provide the necessary information. If your veterinarian reports the adverse event, you do not need to file a report. If your veterinarian has not reported the adverse event, or if your veterinarian was not involved in the treatment, you may need to report the adverse event.
- Different government agencies oversee different products, so the reporting process will vary. The product label or other packaging should indicate the regulatory authority, and your veterinarian can help with this as well.
- Regardless of the government agency involved, the manufacturer should be notified of the adverse event.
- Reporting adverse events allows the government, manufacturers, and veterinarians to investigate and determine if the involved product’s labeling or use should be changed.
- The AVMA strongly encourages veterinarians to report adverse events and has developed the Adverse Event Reporting Policy.
- Veterinarians reporting adverse events provide regulatory authorities and manufacturers with reliable and critical information that is used to monitor and evaluate safety and efficacy of products and devices used in the field.
- Reporting allows authorities and manufacturers to monitor for emerging trends in events, investigate whether the events can be attributed to the given product or device, and take appropriate corrective measures.
- Veterinarians, clients, and patients benefit from adverse event reporting and subsequent actions taken (e.g., label change) if needed.