Canada's New Drug Safety Information Service

Wednesday, June 11, 2014

medicationThe case of a first-year University of Calgary student who died from complications caused by a massive blood clot propelled drug safety into the news in 2013. The suspected culprit, an anti-acne drug known as Diane-35, already had twelve other "adverse reaction reports" filed with the federal regulator.

Still, up to 2013 the Federal Health Department conducted its drug safety reviews in secret. It never published a list of the drugs that it tested or the results of these tests.

Why is it important for drug safety reviews to be publically available?


  • Physicians will prescribe slightly unsafe drugs only in the most necessary cases where all other drugs have failed.

  • Consumers will know which questions to ask when their physicians prescribe these medications for them.

  • It will point to research that is still lacking, and thereby guide the research priorities of other institutions, like universities.

  • Diane-35, for example, has been approved for treating acne, but many physicians also prescribe it as a contraceptive, and many consumers obtain it without their physicians' approval for birth control.

In 2014 the Health Department decided to publish some of the drug reviews to inform Canadian consumers and medical professionals of the safety of the drugs they take and prescribe. In this new transparency campaign, it publishes drug safety summaries on its website. It also makes it possible for readers to request the full safety reports. 

Some criticism of the campaign remains:

  • Drug reviews conducted before 2014 will not be included in the new transparency plan, so millions of Canadians will remain in the dark about the safety of their prescribed medicine.

  • The list of drugs that are reviewed annually is not included in the plan, so consumers do not know which results are being withheld. For example, the 2013 list was made public only when the Toronto Star submitted an official request, and 47 of the 128 drugs reviewed in that year have still not been made public.

The Health Department argues that drug companies currently voluntarily submit possible health risks related to their products, and that they will no longer do so if the department were to release all this information as warnings to the public. Without these voluntary submissions, the department would not know which drugs to submit to further testing.

This new drug safety information initiative is a good step in the right direction and should be cautiously expanded to provide Canadians with the information they need to make informed decisions.

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