CVM ANNOUNCES TOLL-FREE NUMBER FOR REPORTING ADES

FDA¹s Center for Veterinary Medicine (CVM) has a new toll-free telephone number to report suspected adverse drug experiences (ADE). The new number is 1-888-FDA-VETS. Calls will be forwarded to a veterinarian in CVM¹s Division of Surveillance. The number is also equipped with voice-mail to record messages received outside of normal working hours.

CVM monitors reports of adverse drug experiences for animal drug products, medicated feeds, and veterinary devices. The definition of an ADE is 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. Lack of effectiveness is also considered an adverse effect.

During 1995, CVM received more than 3,000 reports. Every report is evaluated by a veterinarian and entered into a computer database. In cases 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 recall; change in product labeling; or, in rare circumstances, removal of a product from the market.