Reporting Adverse Effects to Vaccines, Medicines

An adverse event can be broadly defined as an undesirable occurrence after the use of a vaccine, drug, animal device, insecticide, medicated feed, etc. Multiple federal agencies are involved in taking reports of adverse events in animals, which can make it difficult for owners and veterinarians to easily notify the appropriate agencies.

Adverse reactions can range from a minor swelling at an injection site to salivation and diarrhea following an insecticide administration to acute collapse and death. The treatment of the animal should always come first. However, reporting adverse events for products used on horses is an important follow-up to the incident.

Biological Products
The U.S. Department of Agriculture (USDA) Center for Veterinary Biologics (CVB) oversees biological products (vaccines, antisera, diagnostic kits, etc.) to ensure compliance with the U.S. Virus-Serum-Toxin Act. Consumers and veterinarians are advised to first contact the manufacturer of these products to report an adverse event and obtain advice from their veterinary services departments. Then, a report can be made to the USDA-CVB.

A summary of adverse events reported to the USDA-CVB from 1999-2005 was published in the Journal of the American Veterinary Medical Association. Of the reports received by the CVB for horses, the three most numerous adverse events were classified as systemic (transient fever, malaise, and inappetence), 37.71%; local (localized swelling and pain), 16.50%; and anaphylaxis-hypersensitivity (hives, urticaria, acute collapse), 10.10%.

Veterinary drugs (including dewormers), medicated feeds, and animal devices are regulated by the Food and Drug Administration Center for Veterinary Medicine (FDA-CVM). "Adverse drug experiences" should be reported to the manufacturer first. Alternatively, a report can be made with Form FDA 1932a directly to the CVM. The form can be requested at 888/FDA-VETS (888/332-8387) or can be obtained at CVM's website. Animal and veterinary drug, feed and product recalls are also posted at the above website. Perhaps the most visible FDA-CVM recall was pet food in 2007 for melamine contamination.

Topical insecticides for animals are regulated by the U.S. Environmental Protection Agency (EPA). Any pesticide federally approved by the EPA has an EPA registration number (sometimes written as EPA Reg. No.) on the label, which is needed in the event of reporting an adverse event. Horse owners should report adverse reactions to pesticides to the manufacturer, who is required to forward the information to the EPA. Horse owners can also report an adverse reaction directly to the EPA by following the instructions.

Veterinarians (only) should use the National Pesticide Information Center's Veterinary Pesticide Adverse Effects Reporting portal. In order for agencies to identify trends or spikes in adverse event reports, veterinarians and owners need to take the initiative and file reports with the appropriate manufacturers and federal agencies. Only through this process can a greater "adverse event" be averted.

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Frana, T.S., L.A. Elsken, S.A. Karli, (2006). Summary of adverse event reports for veterinary biologic products received by the USDA from 1999-2005. JAVMA 229(7)1100-1102.


This is an excerpt from the July 2010 issue of Equine Disease Quarterly, funded by Lloyd's of London underwriters, brokers, and their Kentucky agents.

About the Author

Roberta Dwyer, DVM, MS, Dipl. ACVPM

Roberta Dwyer, DVM, MS, Dipl. ACVPM, is a professor within the University of Kentucky's Maxwell H. Gluck Equine Research Center and editor of Equine Disease Quarterly.

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