Report an adverse reaction to a health product
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Everyone who witnesses or experiences an adverse reaction or side effect to a health product is strongly encouraged to report it. You can submit your report in collaboration with your health professional. The health professional could offer additional information that may be useful for our assessment.
What health products are included
Health products include:
- prescription and non-prescription drugs
- products made from biological material, such as:
- biotechnology products
- human blood and blood components
What is an adverse reaction
An adverse reaction is a harmful and unintended response to a drug or health product.
In the case of a drug, a serious adverse reaction may occur at any dose. The reaction is serious when it:
- requires hospitalization
- extends a hospital stay
- causes congenital malformation (birth defect)
- results in persistent or significant disability or incapacity
- is life-threatening or results in death
In the case of a natural health product, you may experience an adverse reaction even under normal use conditions. Reactions may become apparent within minutes or years after exposure. These can range from minor reactions, like a skin rash, to something more serious, like a heart attack or liver damage.
Why you should report
All marketed drugs and health products have benefits and risks. They are carefully tested before they are licensed in Canada. However, some adverse reactions may become evident only after a product is in use by consumers.
Your report helps to indicate if there is an issue with a health product (a signal). Each single case has to be looked at and considered as unique. However, more than 1 report is usually needed to generate a signal.
A signal is an initial indicator of an issue with the drug or health product. However, it is not proof the health product caused the adverse reaction. We evaluate every signal to confirm or disprove a connection between the product and the reaction.
Reporting a suspected adverse reaction helps us:
- identify potential safety issues
- improve health product safety for all Canadians
- identify previously unrecognized, rare or serious adverse reactions
- add to international data on the benefits, risks or effectiveness of drugs and health products
- communicate changes in product safety information to industry, hospitals and consumers
- undertake regulatory actions, such as removing a product from the Canadian market
We carefully examine all reports and take the appropriate steps to protect Canadians.
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