Adverse Reaction Data on Websites

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What is important for consumers to know about adverse reaction data posted on other Canadian websites?

On February 16, 2004, the CBC posted a subset of adverse reaction (AR) data from Health Canada's Canadian Adverse Drug Reaction Information System (CADRIS) database. Health Canada is concerned that the Canadian public may misinterpret this adverse reaction information posted on the CBC website.

Health Canada encourages Canadians to discuss issues of concern with their health care professional (eg. physician, pharmacist) before taking any action such as stopping use of a health product based on information that they have found on websites.

What does this data represent?

Post-market adverse reaction reports are suspected associations which reflect the opinion or observation of the individual reporter. The subset of adverse reaction information posted on the CBC website represents the reporter's observations and opinions, and does not reflect any Health Canada assessment of association between the health product and the reaction(s). Inclusion of a particular reaction in the database does not necessarily mean that it was caused by the suspected health product(s). All factors that may have contributed to an adverse reaction (e.g. drug-dosage, time for onset of reaction, other medical conditions, other concomitant medications) have to be considered when assessing the drug as a possible cause of the adverse reaction.

What are the limitations of this posted subset of AR data?

The adverse reaction data posted on the CBC website cannot be used on its own for the evaluation of a health product's safety. It is an extract of the CADRIS database used by Health Canada to store and retrieve essential information contained in Canadian adverse reaction reports. CADRIS is only one of the tools used by Health Canada to evaluate a health product's safety profile. Comprehensive risk-benefit evaluations include information from post-marketing surveillance on a global scale to determine whether a health product's benefits continue to outweigh its risks.

The use of any health product has associated benefits and risks which must be carefully considered for each individual in consultation with their health care professional(s).

Where else can consumers go for information about adverse reactions?

Adverse reaction information is provided from several sources. Information on adverse reactions, precautions, warnings and contraindications is available for health care professionals and consumers through product information monographs. Product Monographs can be obtained from the market authorization holder of the product. The Compendium of Pharmaceuticals and Specialities (CPS) contains summaries on many Canadian products and can be reviewed with your pharmacist or physician or can be viewed at your local library. If you suspect that you have experienced an AR to a therapeutic health product you should contact your doctor, pharmacist or other health professional.

Currently, Health Canada provides health product safety information to both health care professionals and the general public through:

• the Health Canada website;
• Dear Health Care Professional Letters;
• Notices to Hospitals;
• the Canadian Adverse Reaction Newsletter;
• public advisories and warnings;
• information provided through many other Departmental publications and communications materials; and,
• by attending health care professional conferences to educate regarding Health Canada's adverse reaction reporting program and its health product safety information publications.

Anyone may join the MedEffect e-Notice mailing list which electronically disseminates the Canadian Adverse Reaction Newsletter and notices of health professional communications or consumer advisories from the Marketed Health Products Directorate. To receive the Newsletter and Advisories free by e-mail, go to:
http://www.hc-sc.gc.ca/dhp-mps/medeff/subscribe-abonnement/index-eng.php

How do I report an adverse reaction?

If you think you or someone in your family has experienced a serious adverse reaction to a health product, you are encouraged to report the experience to your health care professional (eg, physician, pharmacist). Your health care provider can provide additional clinical information that may help Health Canada to evaluate the event.

You may also report a suspected AR to a drug marketed in Canada by completing a copy of the AR Reporting Form (Report of suspected adverse reaction due to drug products marketed in Canada (Vaccines excluded) (HC 4016)) at:
AR Reporting Form
or by contacting Health Canada's adverse reaction program toll free at:
Telephone : 1-866 234-2345
Fax : 1-866 678-6789.

How do I find out more on how to use adverse reaction information?

There is a fact sheet on How Adverse Reaction Information on Health Products in Used, posted on the Health Canada Website. You should always discuss questions about adverse reactions with your health professional.
http://web.hc-sc.gc.ca/dhp-mps/pubs/medeff/_fs-if/2005-ar-ei_info/index-eng.php

Date: March 2004

Administrative update: August 2005