This issue of the FDA Veterinarian contains the first in a series of questions and answers that are frequently asked about CVM's Veterinary Adverse Drug Experience (ADE) program. Readers who have additional questions on our ADE program or any other Center issue are encouraged to submit them to the following address: FDA/Center for Veterinary Medicine, 7500 Standish Place, HFV-12, Rockville, MD 20855 or telephone Linda Grassie at (301) 594-5909.

Q. What is an ADE?

A. An adverse drug experience (ADE) is either an undesired side effect, or the lack of a desired effect. CVM's official definition of an ADE is "any side effect, injury, toxicity, or sensitivity reaction (or failure to perform as expected) associated with the use of an animal drug, whether or not determined to be attributable to the drug."

Q. What are CVM's specific areas of interest?

A. The primary purpose of CVM's ADE monitoring system is to detect problems or "side effects" associated with the use of FDA approved animal drugs. During the research studies that lead to drug approval, only limited numbers of animals are treated. Because of this, effects or problems that only occur rarely may not be discovered until after the drug has been more widely marketed and used in a clinical setting.

Lack of effectiveness is an adverse experience. The majority of reports of this nature involve anthelmintics. These reports can be difficult to evaluate, but a group of similar reports will prompt further investigation.

CVM gives careful consideration to any reports of adverse experiences occurring in humans as a direct result of using or administering an animal drug or in other situations involving accidental human exposure.