Reporting Adverse Drug Reactions

Users of new animal drug products are encouraged to notify the product's sponsor of any unexpected or adverse reactions resulting from the use of that product. Among the data which must be submitted by the sponsor to FDA are reports of injury, toxicity, sensitivity reaction, unexpected incidence or severity of side-effects associated with use, or failure of the drug to exhibit expected pharmacological action. FDA scientists analyze these data to determine if any modifications are needed in the drug's labeling, dosage level, etc., to mitigate future adverse reactions. In extreme instances, the adverse reactions may be so severe as to request withdrawal of approval of the drug.

FDA also encourages veterinarians to report adverse drug reactions directly to the Agency. The reports should be submitted on Form FDA 1932a, Veterinary Adverse Reaction, Lack of Effectiveness, or Product Defect Report. This is a pre-addressed, postage-paid form which is filled out and dropped in the mail by the veterinarian. Copies of the form are also usually available from State veterinary medical associations, clinics of colleges of veterinary medicine, USDA Extension Service veterinarians, and FDA offices. FDA may occasionally need more detailed information about an incident, and the veterinarian may be called by an FDA staff veterinarian.

Adverse reactions may be reported by telephone during normal working hours (7:00 a.m. to 4:00 p.m. Eastern Standard/Daylight Time) by calling 888-FDA-VETS (888-332-8387) or after hours by dialing 888-FDA-VETS (888-332-8387) and leaving a message. In the second case, a message is recorded and the call is returned by a veterinarian the following working day.