Monitoring adverse reactions to veterinary drugs - Pharmacovigilance

The Food and Drug Administration Center for Veterinary Medicine (CVM) monit ors reports of adverse drug experiences (ADE) for animal drug products, med icated feeds, and veterinary devices. The term most frequently applied to t his 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 algori thm and entered into a computer database. In instances where public or anim al health is judged to be at risk, the initial review leads to follow-up ac tivity. The final result can be a product safety communication, change in l abeling, or in rare circumstances, removal of the product from the market o r even withdrawal of FDA approval to market the product. The purpose of thi s article is to provide a brief description of the pharmacovigilance progra m for animal drugs in food-producing animals, and answer some of the more c ommonly received questions about adverse experience reporting.