June 17, 2010
For immediate release
Backgrounder: Consumer Side Effect Reporting Form
OTTAWA - Health Canada has launched a new Consumer Side Effect Reporting Form to make it even easier for consumers to report side effects to drugs and other health products to the Canada Vigilance Program.
Reporting side effects, also known as adverse reactions, is important to health product safety. Each report may contribute to improving the safe use of health products - including prescription and non-prescription drugs, and natural health products.
"Improving health product safety is in everyone's best interest, and everyone has a role to play," said the Honourable Leona Aglukkaq, Minister of Health.
"The new form is one way Health Canada is making it easier for Canadians to report suspected adverse reactions, and for us to improve the safety and safe use of health products for all Canadians."
Information received from adverse reaction reports is combined with other sources of safety information and may help identify previously unrecognized, rare or serious adverse reactions, and may lead to changes in product safety information or other regulatory actions.
In addition to the new form, which can be sent by postage-paid mail or by toll-free fax, consumers can also report online or by calling toll-free at 1-866-234-2345. The Consumer Side Effect Reporting Form and other information on reporting side effects is available at the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
Health Canada reminds consumers that all side effects, especially serious ones, should be reported immediately to a health professional. Consumers are encouraged to seek assistance from their health professional to report a side effect to Health Canada.
Health Canada's MedEffect™ Canada initiative provides centralized access to new safety information about marketed health products and makes it quick and easy to submit adverse reaction reports.
As part of this initiative, the Canada Vigilance Program plays an important role in Health Canada's post-market surveillance by managing the collection and analysis of adverse reaction reports by health professionals, consumers and industry.
"Consumer Side Effect Reporting Form" is one of three side effect reporting forms available on the MedEffect TM Canada Web site. The other two forms are for health care professionals (who report adverse reactions voluntarily), and industry (which are required to report adverse reactions).
For the latest health product safety information or to subscribe to the MedEffect e-notice, visit the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect. For more ways to stay connected to Health Canada information through social media, visit Health Canada's website.
Office of the Honourable Leona Aglukkaq
Federal Minister of Health