This issue of the FDA Veterinarian contains the fifth in a series of questions and answers that are frequently asked about CVM's Veterinary Adverse Drug Experience (ADE) program.

Q. Why should veterinarians in practice care about reporting an ADE?

A. Veterinarians in practice depend on the information available in drug labeling to make informed choices about the risks and benefits associated with the use of a drug. The purpose of ADE monitoring is to ensure that animal drug labeling is adequate and accurate.

In spite of the highest standards for safety and effectiveness that exist for FDA approval, not everything is known about a drug when it is first marketed. Due to the limited size and controlled nature of premarketing clinical trials, only the most common adverse events will be observed and included in product labeling at the time of FDA approval. An accurate safety profile emerges only after a product is marketed and the number and spectrum of animals receiving the drug increases.

As a practicing veterinarian, you are in a unique position to observe adverse clinical outcomes associated with the use of drug products. Some of these problems may only be associated with extra-label drug use. You can assist in the development of a complete safety profile by reporting adverse experiences. Such reports are often the first signal that a problem exists. By participating in the reporting program and contributing to our knowledge of animal drugs, you provide a valuable service to animals, the public, and your colleagues in the veterinary profession.

Q. Where can I obtain information for a specific drug concerning potential adverse reactions?

A. The drug manufacturer is usually the best source for this type of information. Other sources include the FDA Center for Veterinary Medicine, the FDA/CVM Internet World Wide Web server (http://www.cvm.fda.gov/), the National Animal Poison Control Center and veterinary computer networks, such as VIN (America Online) and NOAH (Compuserve).