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.

• Adverse Drug Reactions (Pharmacovigilance) Contacts
• Notice of Suspected Adverse Reaction to Veterinary Drugs

Advisories, Warnings and Recalls

• Fentanyl Transdermal Pain Patches recalled due to health risk
• Health Canada advises about missing dosage information on the veterinary drug product PENPRO
• Advisory: Health Canada is advising Canadian farmers about missing dosage information on some Selenium-E veterinary drug packages
• Counterfeit Product Linked to Death of Ontario Horse
• Advisory Letter to Stakeholders Regarding the Use of Hormonal Growth Implants in Veal Calves
• Important Safety Updates - Letter to Veterinarians (Micotil)
• Notice to Hospitals (Micotil)

Links:

Canada - Government Organizations and Information

Veterinary Drugs Directorate - Antimicrobial Resistance

Marketed Health Products Directorate (MHPD)

Adverse Reaction Information

Health Products and Food Branch (HPFB) Inspectorate: Acts and Regulations

Health Products and Food Branch Drug Products Database

 Canadian Food Inspection Agency (CFIA), Animal Health and Production Division: Veterinary Biologics Section

 Guidelines for Reporting Suspected Adverse Reactions to Veterinary Biologics

 Form for Notification of Suspected Adverse Reactions to Veterinary Biologics (CFIA-2205) (PDF Version)

Pest Management Regulatory Agency (PMRA)

Cosmetics programme, Healthy Environments and Consumer Safety Branch

Canada - Other Organizations

 Canadian Veterinary Medical Association (CVMA)

International - Government Organizations

 US Food and Drug Administration (FDA), Centre for Veterinary Medicine (CVM)'s Adverse Drug Experience Reporting

 VICH (International Conference on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products)

 Australian Pesticides and Veterinary Medicines Authority (APVMA), Adverse Experience Reporting Programme for Veterinary Chemical Products

 European Agency for the Evaluation of Medicinal Products (EMEA), Veterinary Medicines and Inspections

 Veterinary Medicine Directorate (United Kingdom); Suspected Adverse Reaction Reporting Scheme (SARRS)