Learning More About Adverse Drug Reactions

According to Health Canada more than 50 per cent of newly launched medications have serious adverse drug reactions that show up in the post-marketing setting. Even more alarming, three-quarters of medications currently out on the market have not been tested in children.

Each year thousands of children are admitted to emergency departments across the country. Some of these reactions are mild and children are able to go home quickly – but others can have devastating effects.

Clearly, drug reactions are more common than many people think. Would you know what to do if someone had an adverse reaction?

Here are answers to commonly asked questions about adverse drug reactions.

Who Can Report an Adverse Reaction?

Anyone — including consumers, patients, caregivers, physicians, pharmacists, nurses, and dentists can report an adverse reaction to drugs or health products on the Canadian market.

Reporting is voluntary for the general population, but is mandatory for Market Authorization Holders (MAH) as required by Canada’s  Food and Drugs Act.

What to Report?

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. Health Canada wants to know about all suspected adverse reactions, but especially if they are:

• unexpected (not consistent with product information or labelling), regardless of their severity;
• serious, whether expected or not; or
• related to a health product that has been on the market less than 5 years.

When to Report an Adverse Reaction?

You should report an adverse reaction soon after the reaction occurred, even if you are not certain that a particular health product was the cause.

Why Report an Adverse Reaction?

All marketed drugs and health products have benefits and risks. Although health products are carefully tested before they are licensed in Canada, some adverse reactions may become evident only after a product is in use by the general population.

Your report may contribute to:

• the identification of previously unrecognized rare, or serious adverse reactions;
• changes in product safety information or other regulatory actions such as the withdrawal of a product from the Canadian market;
• international data regarding benefits, risks or effectiveness of drugs and health products; and
• health product safety that benefits all Canadians.

For more information, visit the Adverse Drug Reaction reporting page.