Monitoring adverse reactions to veterinary drugs. Pharmacovigilance

The Food and Drug Administration Center for Veterinary Medicine (CVM) monitors reports of adverse drug experiences (ADE) for animal drug products, medicated feeds, and veterinary devices. The term most frequently applied to this monitoring activity is pharmacovigilance. An ADE is either an undesired effect or the lack of a desired effect. During 1997, the CVM received over 4,000 reports. Every report is evaluated by a veterinarian using an algorithm and entered into a computer database. In instances where public or animal health is judged to be at risk, the initial review leads to follow-up activity. The final result can be a product safety communication, change in labeling, or in rare circumstances, removal of the product from the market or even withdrawal of FDA approval to market the product. The purpose of this article is to provide a brief description of the pharmacovigilance program for animal drugs in food-producing animals, and answer some of the more commonly received questions about adverse experience reporting.