http://www.canada.com/health/story.html?id=b5b86669-dc6d-496a-
-95dd-7951ef925654

Health Canada posts adverse drug reaction database on
the Internet

Canadian Press

May 26, 2005

OTTAWA (CP) - 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.

*******

http://www.cbc.ca/news/adr/database/

TC