• Animal Health
 /  
• Veterinary Biologics
 /  
• Adverse Events

Adverse Event Reporting

An adverse event is any undesirable occurrence after the use of an immunobiological product, including illness or reaction, whether or not the event was caused by the product. For products intended to diagnose disease, adverse events refer to anything that hinders discovery of the correct diagnosis.

The mission of the Center for Veterinary Biologics (CVB) is to ensure that animal immunobiologics are in compliance with the Virus-Serum-Toxin Act. Reports are assessed for the possibility of a product deficiency. When necessary, testing is performed or additional information sought. The CVB is, however, unable to make diagnoses or recommendations specific to individual cases. Some of the manufacturers do provide such services. Receipt of a report by the CVB does not necessarily imply that the product caused an adverse event, or even that a particular event actually occurred.

Adverse events may be reported to the:

• Manufacturer - The CVB encourages the public to submit adverse event reports to the manufacturer of immunobiological products. Many manufacturers maintain veterinary services departments to handle such reports and may also offer diagnostic advice, treatment recommendations and guidance on product use. Please note that reporting adverse events to the manufacturer cannot be done from this website. You will need to contact the manufacturer directly. A contact telephone number may be available on the label of the product.

• Center for Veterinary Biologics - Once an adverse event has been reported to the manufacturer, the CVB may be contacted.

  • On-line (preferred method): USDA Adverse Event Reporting

    • Guidance notes on the use of VeDDRA terminology (for licensed firms)

    • Complete VeDDRA list (for licensed firms)
      

  • Fax or mail: Download and complete the Adverse Event Report Form (APHIS 2080) and FAX to (515) 337-6120 or submit to the CVB by mail at:

                             Center for Veterinary Biologics
                             1920 Dayton Avenue
                             P.O. Box 844
                             Ames, Iowa 50010

• • Telephone: Call the CVB at (800) 752-6255.

• Veterinary drugs, medicated feeds, and animals devices are regulated by the Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) under the Food, Drug and Cosmetic Act. The CVM recommends that you first contact the manufacturer to report an adverse event. To contact the CVM directly, call (888) FDA-VETS.

• Topical insecticides. Most of the products used topically for the control of ectoparasites and insects on animals are regulated by the Environmental Protection Agency (EPA) under the Federal Insecticide Fungicide and Rodenticide Act. To contact the EPA directly, call (800) 858-7378.

See Frequently Asked Questions on adverse event reporting/pharmacovigilance.