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Health Canada Posts Adverse Drug Reaction Database on the Internet

May 26, 2005 | Canadian Press

Anyone with an online connection can now check out Health Canada's website to look at adverse drug reactions that have been reported since 1965.

Health Minister Ujjal Dosanjh announced Wednesday the launch of a searchable online database that allows direct access to reported adverse reactions in the Canadian Adverse Drug Reaction Information System (CADRIS).

The database contains reports of suspected adverse reactions from consumers, medical personnel and drug makers. The information is as recent as December 2004 and will be updated quarterly.

"Making this adverse reaction information directly available to the Canadian public, patients, advocacy groups, medical professionals, researchers and product manufacturers is a major step forward in Health Canada's transparency agenda," Dosanjh said in a statement.

"Monitoring of adverse reactions helps ensure that the benefits of a health product continue to outweigh the risks. It also helps us update product labelling and information."

The database has been available online at cbc.ca/news (follow the links) since early last year when CBC acquired it using the federal Access to Information Act.

Sue Gardner, senior director of CBC.ca, said she's "absolutely delighted" that Health Canada is posting the database and the CBC will eventually take down the one on its site.

"We didn't have any funding to maintain it and to keep the information current, and so that was a worry for us," she said. "So now we're delighted because Health Canada is going to put it up, they're going to make it available for Canadians and they're going to maintain it, which is great."

The CBC database has had more than 123,000 visits since February 2004.

Canadians also have had access to the information by requesting adverse reaction reports from CADRIS, but there was a minimum wait time of two weeks.

The database can be searched by the name of the product or active ingredient, the date a report was received, patient age and gender, and the outcome of the adverse reaction. There is no confidential information about the patient.

But the information does come with a caveat.

"Accumulated case reports should not be used as a basis for determining the incidence of a reaction or estimating risk for a particular product as neither the total number of reactions occurring, nor the number of patients exposed to the health product is known," the website states.

"In some cases, the reported clinical data is incomplete and there is not certainty that these health products caused the reported reactions. A given reaction may be due to an underlying disease process or to another coincidental factor."

Jeff Connell, director of public affairs for the Canadian Generic Pharmaceutical Association, welcomed the launch of the website, and added that any patient decisions about medications should take place after consultation with a physician.

The site contains information on prescription and non-prescription drugs, natural health products, biological products (including vaccines), and radiopharmaceuticals.


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