Has your pet suffered an adverse reaction to a drug, pesticide or vaccine? Adverse events to these products occur with alarming frequency but sadly, they are often under-reported. This leads to an inflated sense of safety when it comes to these products. If you suspect your dog or pet has suffered an adverse reaction from any medication or vaccination, please report not just to your vet, but to the agency responsible for investigating the safety of these products.
To report an adverse event associated with a veterinary drug the AVMA advises that you contact the manufacturer. They are required to report this information to the FDA.
If the drug in question is not FDA-approved, or if the event involves a medical device, contact the FDA directly. For more information regarding the process of reporting adverse events to the FDA, go to: www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm
To report an adverse event associated with a pesticide (such as a flea and tick product), you should notify the National Pesticide Information Center (NPIC) or the EPA Office of Pesticide Programs (OPP):
REPORTING TO NPIC:
REPORTING TO EPA:
Contact the EPA at pesticides.supportportal.com. It will be most helpful if you include the following information:
Name(s) and EPA registration number(s) of the product(s) (these numbers can be found on the product label);
Breed(s) and age(s) of animal(s) and any other factors needed to understand the animals’ previous medical conditions;
Who applied the product (e.g., the owner or the veterinarian);
Length of time between application and reaction;
Description of adverse reaction;
Date, City, and State in which adverse reaction occurred; and
Contact information and telephone number.
You can also call the National Pesticide Information Center at 800-858-7378 to report an incident.
The EPA is responsible for regulating pesticide products in the US and ensuring that they can perform their intended functions without posing unreasonable risks to humans, animals or the environment. All reports are included in the EPA’s Pesticide Incident Data System, which contains information on reported pesticide poisonings. EPA routinely examines information from the database to determine what concerns are being raised about registered products and whether further regulatory action is needed.
For more information about EPA’s effort to evaluate spot-on flea and tick products and other related information, see www.epa.gov/pesticides/health/pets.htm.
To report an adverse event associated with a vaccine or other biological product, contact the US Department of Agriculture (USDA)’s Center for Veterinary Biologics (CVB):
Go to https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/adverse-event-reporting/ct_vb_adverse_event to view information on reporting adverse events. The adverse event reporting form can be accessed from that page and submitted electronically, or it can be mailed or faxed to the CVB. Adverse events may also be reported by calling the CVB at (800) 752-6255.
To report an adverse event associated with pet food, submit a report to the FDA at www.safetyreporting.hhs.gov.
For more information about the FDA’s role in pet food regulation, go to www.fda.gov/cvm/petfoods.htm.
To report an adverse event associated with other animal feed, please contact your state FDA’s Consumer Complaint Coordinator(s). Contact information can be found on the FDA’s Web site at www.fda.gov/opacom/backgrounders/complain.Html. When reporting, please include as much information as possible, including the specific product name, lot numbers, veterinarian’s report and diagnosis, and any other pertinent information. It is preferred, however, that you ask your veterinarian to contact the FDA, because your veterinarian can often provide additional information and details that can aid the investigation.
Report suspected adverse reactions to drugs used in animals – including a lack of effect – through the Adverse Drug Reactions (Pharmacovigilance) web site. You will also find safety information such as advisories, warnings, and recalls for veterinary products on the Veterinary Drugs Directorate section of the Health Canada Web site.
Report any incident related to a pesticide, whether it involves adverse effects on a human, an animal, or the environment, to the manufacturer using the contact information available on the pesticide label. Manufacturers are required by law to report to Health Canada any incident information they receive related to their product.
You may also report an incident directly to Health Canada by using the appropriate Pesticide Incident Reporting Form for the Public available on the Pesticide Incident Reporting page.
If you suspect an adverse reaction to a vaccine, the Veterinary Biologics Section (VBS) of the Canadian Food Inspection Agency (CFIA) should be notified. Veterinary biologics include the following classes of products: vaccines against viral, bacterial, protozoan and fungal diseases, antibody products for the prevention or treatment of infectious diseases in animals and vitro diagnostic kits, including those derived through biotechnology.
The Guidelines for Reporting Suspected Adverse Events to the Veterinary Biologics Section (VBS) provide more information. The recommended form used to notify VBS of suspected adverse reactions is available for downloading from the Guidance for Reporting Suspected Adverse Events Web site.