Adverse Event Reporting

Adverse Drug Experience Reporting

Important information about product safety is gathered from the experiences veterinarians and pet owners have with a product after it is approved and enters the market. Putney is committed to ensuring the safe use of drugs in pets and encourages the reporting of adverse drug experiences.

What are Adverse Drug Experiences?

Adverse Drug Experiences (ADEs) include any adverse event associated with the use of an animal drug, such as a side effect, injury, toxicity, or sensitivity reaction, whether or not the event is related to or caused by use of the drug.

Adverse drug experiences include, but are not limited to:

  1. Adverse events occurring in animals in the course of use by a veterinarian or a pet owner;
  2. Adverse events resulting from extra-label use of the drug (i.e., use of an animal drug in veterinary practice in a manner other than that prescribed by the product labeling or use in veterinary practice of a human-approved drug)
  3. Adverse events occurring in humans from exposure during manufacture, testing, handling, or use of a new animal drug;
  4. Failure of a new animal drug to produce its expected pharmacological or clinical effect (lack of expected effectiveness);
  5. Product defects or unintended effects on the environment.

See 21 CFR 514.3 and "Pharmacovigilance of Animal Drugs, Adverse Drug Event Reporting System," 04/01, Center for Veterinary Medicine Brochure.

How are Adverse Drug Experiences Reported?

It is important that veterinarians and pet owners report ADEs to the product distributor or manufacturer. Manufacturers investigate, review, and track ADEs. From ADE reports, manufacturers might determine that a manufacturing deviation occurred in a particular lot or that product labeling changes are needed. By law, manufacturers must report ADEs to FDA’s Center for Veterinary Medicine (CVM). CVM monitors ADEs, makes information available to veterinarians and pet owners, and determines if ADEs warrant regulatory action.

For ADEs, product complaints, or product inquiries related to Putney products, please contact:

Putney Veterinary Services
(866) 683-0660
vet.relations@putneyvet.com

Veterinarians and pet owners can also report ADEs to CVM. CVM shares these reports with the product manufacturer. You can report ADEs directly to CVM via FDA Form 1932a, available by calling 1-888-FDA-VETS or online: Veterinary Adverse Experience, Lack of Effectiveness or Product Defect Report,.

For additional information on ADEs, visit CVM’s website athttp://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm or contact Putney Veterinary Services.