Announcement - Launch of the Re-designed Canada Vigilance Adverse Reaction Online Database

November 13, 2009

Health Canada is pleased to announce the launch of a more user-friendly version of the Canada Vigilance Adverse Reaction Online Database.

The Canada Vigilance Adverse Reaction Online Database contains a subset of the information reported to Health Canada about suspected Canadian adverse reactions to health products such as prescription and non-prescription drugs, natural health products, biologics and radiopharmaceuticals. Information concerning preventative immunization vaccines, blood, blood components, medical devices, and cosmetics is not included in this database.

This new version of the Canada Vigilance Adverse Reaction Online Database includes the following enhancements:

1. The search criteria page layout has been simplified;
2. The ability to search brand name(s) or active ingredient name(s) of a health product has been added;
3. The ability to search by reported adverse reaction term(s) or group(s) of adverse reactions terms has been included;
4. Additional help and background information have been provided to the user;
5. The ability to print/save/export search results in the Adobe PDF File Format or Microsoft Excel File Format has been provided.

The data presented in the Canada Vigilance Adverse Reaction Online Database was also updated and now includes information received by Health Canada up to June 30, 2009. The next update of data is scheduled for December 31, 2009 and will include information received by Health Canada up to September 30, 2009.

This online database will be updated quarterly with new data; since this data is a subset of the internal Health Canada database where new information is added daily, every update to the online database will be a replacement of the data in its entirety, plus data from the new quarter. Each new quarterly update contains adverse reaction information that is one quarter behind the actual release date to allow for the complete entry of new reports as well as follow-up information to existing reports.

While the database does allow consumers to see what types of adverse reactions have been reported by people taking a particular product, it is important to remember that the information represents the opinions of the people who make the reports. The database does not provide conclusive information on the safety of health products, and is not a substitute for medical advice. Canadians can obtain new safety information related to drugs and other health products in the Advisories, Warnings and Recalls section of the MedEffect™ Canada Web site.

It is also important to note that the information related to the identity of the patient and/or the reporter of an adverse reaction is protected under the  Privacy Act and cannot be retrieved through the online database.

For more information about the Canada Vigilance Adverse Reaction Online Database and how to report an adverse reaction, visit the MedEffect™ Canada section of the Health Canada Web site at www.healthcanada.gc.ca/medeffect.