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Drugs and Health Products

Adverse Drug Reactions (Pharmacovigilance)

Once new veterinary drugs are authorized for sale in Canada, it is important to monitor these drugs and their effects while they are in more widespread use. To meet this need, Health Canada's Veterinary Drugs Directorate (VDD) formalized its pharmacovigilance program.

Pharmacovigilance or post-market surveillance includes the collection and analysis of suspected Adverse Drug Reactions (ADRs). An ADR is an unintended reaction to a drug resulting in mild to severe adverse symptoms. The purpose of this activity is to monitor:

  • the safety and efficacy of veterinary drugs used in animals; and
  • the safety of humans handling these products and consuming food derived from treated animals.

Canada's Food and Drugs Act and Regulations require manufacturers to report all suspected adverse drug reactions to Health Canada.

Veterinarians and technicians are the first point of contact for adverse drug reaction reporting in clinical practice. Although there are no regulations requiring veterinary practitioners to report ADRs, VDD encourages veterinarians to report suspected adverse reactions to any drugs which occur in their practices to the manufacturer or to VDD. A fact sheet For Your Information: Adverse Drug Reactions (Pharmacovigilance) and Questions and Answers - ProHeart«6 Injectable Heartworm Product for Dogs provide additional details. For information on national and international efforts to address this issue please refer to these links.

Advisories, Warnings and Recalls

Links:

Canada - Government Organizations and Information

Canada - Other Organizations

International - Government Organizations