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QUESTIONS AND ANSWERS ON ADES This issue of the FDA Veterinarian contains the fourth in a series of questions and answers that are frequently asked about CVM's Veterinary Adverse Drug Experience (ADE) program. Q. What happens after I report an ADE? A. Each ADE report is evaluated by a veterinarian and entered in a computer database. The reviewer assigns codes to items that describe the drug(s) and animal(s) involved. These items become separate fields of information. The reviewer also enters a brief clinical description of the ADE, and makes an assessment of whether the event is judged to be drug related using an algorithm scoring system. CVM publishes an annual summary of ADE reports. The summary provides the number
of reports and the clinical signs associated with each drug in the database.
The information is limited to those reports that were assessed as at least "possibly
drug related". The publication is available from the FDA Center for Veterinary
Medicine. CVM also anticipates providing the ADE annual summary on a World Wide
Web Internet server. Q. What actions result from reports of ADEs? A. A group of similar reports submitted in a short period of time may alert CVM and the drug company to a problem with a particular lot of drug. This may result in a product recall of the affected lot. Another outcome would be for a label change to include new information gleaned from reported ADEs. The changes may include new warnings, contraindications or human safety information. In very rare instances, a drug may be removed from the market due to problems discovered by ADE reporting. At times, CVM may require the involved drug company to issue a "Dear Doctor" letter to veterinarians informing them of the type of actions that had resulted from ADE reports.
prev | next Source: May/June 1996 FDA Veterinarian Newsletter |
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