Adverse veterinary drug reactions
An adverse veterinary drug reaction is any unwanted or harmful event that occurs after administration of a veterinary drug (off-label and/or on-label). Included are adverse reactions/events in animals and/or humans involved in administering a veterinary drug to an animal, and events that result from a suspected lack of effect/response.
Anyone can report suspected adverse reactions to veterinary drugs. Veterinary health care professionals and animal owners are encouraged to submit reports. However, reporting is mandatory for manufacturers, as per the Canada's Food and Drug Regulations.
An adverse reaction/event should be reported as soon as possible after the reaction has occurred, even if you are not certain that a particular veterinary drug is the cause.
Steps to report an adverse veterinary drug reaction
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Health Canada's Veterinary Drugs Directorate (VDD) monitors the safety and efficacy of approved drugs for the prevention, diagnosis and treatment of disease in animals through its pharmacovigilance program. The purpose of this surveillance is to monitor:
- the safety and efficacy of veterinary drugs used in animals
- the safety of humans handling these products
- the safety of consuming food derived from treated animals
Records of suspected adverse veterinary drug reaction reports are reviewed and assessed to find out if they are related to the administered drug(s). This process is conducted in accordance with the international guidelines for pharmacovigilance activities developed by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).
For more information
- Adverse Reaction Information
- Advisories, Warnings and Recalls – Drugs and health products
- Drug Product Database
- Canadian Food Inspection Agency (CFIA): Veterinary Biologics
- Guidelines for Reporting Suspected Adverse Reactions to Veterinary Biologics
- Report an incident involving a pesticide
- Report an incident involving a consumer product or cosmetic
- Canadian Veterinary Medical Association (CVMA)
- Marketed Health Products Directorate (MHPD)
- VICH (International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products)
- US Food and Drug Administration (FDA), Centre for Veterinary Medicine (CVM) Adverse Drug Experience Reports
- Australian Pesticides and Veterinary Medicines Authority, Adverse Experience Reporting Program for Veterinary Medicines
- European Agency for the Evaluation of Medicinal Products (EMEA), pharmacovigilance of veterinary medicines
- Gov.uk (United Kingdom), Report a suspected problem with an animal medicine or microchip
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