About Adverse Reaction Reporting
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Why report?
All marketed health products have benefits and risks. Although health
products are carefully tested for safety and efficacy before they are
licensed, some adverse reactions* may not become evident until the general
population uses a health product under "real life" circumstances.
By submitting a suspected adverse reaction report, you are contributing
to the ongoing collection of safety and effectiveness information that
occurs once health products are marketed.
Reported adverse reaction information may contribute to:
- the identification of previously unrecognized rare, or serious adverse
reactions;
- changes in product safety information, or other regulatory actions
such as withdrawal of a product from the Canadian market;
- international data regarding benefits, risks, or effectiveness of
health products;
- health product safety knowledge that benefits all Canadians.
What to report?
Health Canada, through the Canadian Adverse Drug Reaction Monitoring
Program, is responsible for collecting and assessing adverse reaction
reports for the following health products marketed in Canada: pharmaceuticals,
biologics (including fractionated blood products as well as therapeutic
and diagnostic vaccines), natural health products and radiopharmaceuticals.
You do not have to be certain that a health product caused the reaction
in order to report it. Adverse reaction reports are, for the most part,
only suspected associations.
We want to know about all suspected adverse reactions, but especially
if they are:
- unexpected adverse reactions, regardless of their severity
(not consistent with product information or labelling);
- serious adverse reactions**, whether expected or not;
- adverse reactions related to recently marketed health products
(on the market for less than 5 years).
When to report?
As soon as possible!
How to submit a report?
Complete the adverse reaction reporting form which can be obtained through the following:
Submit the report.
By toll-free fax: 1-866-678-6789
By toll-free phone: 1-866-234-2345
(calls are automatically directed to the appropriate regional adverse reaction monitoring office)
Stay Informed
By signing up for the MedEffect e-Notice
mailing list, you will automatically receive the most recent Canadian
Adverse Reaction Newsletter and health product advisories free by e-mail.
* adverse reaction = side effect
** A serious adverse reaction is one which requires inpatient hospitalization
or prolongation of existing hospitalization, causes congenital malformation,
results in persistent or significant disability or incapacity, is life-threatening
or results in death. Adverse reactions that require significant medical
intervention to prevent one of these outcomes are also considered to be
serious.
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