What is an ADE?
In common terms, an adverse drug experience (ADE) is either an undesired side effect, or the lack of a desired effect. The Center for Veterinary Medicine (CVM) defines an ADE as “any side effect, injury, toxicity, or sensitivity reaction (or failure to perform as expected) associated with use of an animal drug, whether or not determined to be attributable to the drug.” What are the FDA Center for Veterinary Medicine’s specific areas of interest? The primary purpose of our 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 a limited number 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 anesthetics, tranquilizers, and anthelmintic
