Reporting Adverse Events

Updated May 2010

Adverse events are undesirable effects that occur after the use of a medication, medical device, pesticide, or vaccine or other biological product. They 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.

Advice for Animal Owners  |  Advice for Veterinarians

Advice for Animal Owners

Although controlled studies are performed to evaluate the safety and efficacy of these products, these studies might not identify small groups of animals at higher risk of experiencing adverse events. Post-marketing monitoring of adverse events provides the government, manufacturers and veterinarians with critical information about the safety and efficacy of products. If adverse events occur, reporting them allows the government, manufacturers and veterinarians to investigate and determine if the product's labeling or use should be changed. Adverse events are rare and the majority of them are minor, but some can be life-threatening.

Consult with your veterinarian about the possible adverse events associated with the medication and/or vaccine, and contact your veterinarian 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. Regardless of the government agency involved, the manufacturer should be notified of the adverse event.

To report an adverse event associated with a veterinary drug, you should contact the manufacturer. The manufacturer is required to provide 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: http://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:

Go to www.npic.orst.edu/reportprob.html.

REPORTING TO EPA:

Go to http://pesticides.custhelp.com. Select the "Ask a Question tab." Type "pet incident" in the search box, and follow the resulting information to submit a report for any animal. It will be most helpful if you include the following information:

  1. Name(s) and EPA registration number(s) of the product(s) (these numbers can be found on the product label);
  2. Breed(s) and age(s) of animal(s) and any other factors needed to understand the animals' previous medical conditions;
  3. Who applied the product (e.g., the owner or the veterinarian);
  4. Length of time between application and reaction;
  5. Description of adverse reaction;
  6. Date, City, and State in which adverse reaction occurred; and
  7. Contact information and telephone number.

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 http://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 http://www.aphis.usda.gov/animal_health/vet_biologics/vb_adverse_event.shtml 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 http://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 http://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.


Advice for Veterinarians

Veterinarians reporting adverse events provides the government and the manufacturers with reliable and critical information that is used to evaluate the actual safety and efficacy of products used in the field. Reporting allows the government and manufacturers to monitor for emerging trends in events and then investigate whether or not the events can be attributed to the product or device. Veterinarians and their patients and clients benefit from communicated updates of such clinically relevant information. The field evaluations provide these agencies with the ability to take appropriate action such as a product recall or a product label change. The AVMA strongly encourages veterinarians to report adverse events. The following guidance will help you navigate the reporting process.

Different government agencies oversee different products, so the reporting process will vary. Regardless of the government agency involved, the manufacturer should be notified of the adverse event.

To report an adverse event associated with a veterinary drug, you should contact the manufacturer. The manufacturer is required to provide 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: http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm

To report an adverse event associated with a pesticide (such as a flea and tick product), veterinarians should click here. Member registration is required in order to verify that only veterinarians and their staff report these incidents.

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.

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 http://www.aphis.usda.gov/animal_health/vet_biologics/vb_adverse_event.shtml 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 http://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 http://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.