Reporting an Adverse Drug Reaction

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If your dog has been given a medication which appears to have an adverse effect, read this publication to find out what you should do.

How to Report An Adverse Drug Experience

Introduction

Veterinarians and animal owners are encouraged to report adverse experiences and product failures to the government Agency that regulates the product in question. Pretesting by the manufacturer and review of the data by the government does not guarantee absolute safety and effectiveness due to the inherent limitation imposed by testing the product on a limited population of animals. CVM encourages you to contact the manufacturer of a suspect product. Reporting information for the following product categories:

Animal Drugs and Devices
Veterinarians and animal owners may report adverse drug experiences to FDA by:

A. You should first call the drug company to report an ADE for an FDA-approved animal drug. Drug company phone numbers can usually be obtained from product labeling. Inform the drug company that you wish to report an ADE, and ask to speak to a technical services veterinarian. The technical services veterinarian should ask a series of questions about the event, complete the FDA 1932 form, and forward the report to CVM. In addition, the technical services veterinarian may also contact the veterinarian who treated your pet to obtain more information regarding the ADE. If the drug is not FDA-approved for animal administration, or if it is approved but you do not wish to contact the manufacturer, the report may be submitted directly to the FDA on Form 1932a. Reports should preferably include a good medical history, all concomitant drugs the animal has been given, any recent surgical procedures, and as much in the way of clinical findings as is possible. Clinical findings would include veterinary exam, clinical chemistries, complete blood counts, urinalysis, fecal exams, radiographic results, and hemodynamic data such as blood pressure, any other pressure measurements in or around the heart, and neurologic assessments.

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