Health Canada comments on expert panel report, releases COX-2 scientific review

News Release

Backgrounder:
Health Canada's Scientific Review of COX-2-Selective Drugs
2006-47
June 14, 2006
For immediate release

OTTAWA -- Health Canada released today two documents as part of its ongoing evaluation of COX-2-selective drugs: its official comments on the advice provided by the COX-2 Expert Advisory Panel and a report on the Department's scientific review of certain COX-2s.
Health Canada's review of the cardiovascular risks (e.g. heart attack and stroke) associated with COX-2 Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) was started after Vioxx, a COX-2-selective inhibitor, was withdrawn from the worldwide market by its manufacturer in September 2004. COX-2 drugs inhibit the COX-2 enzyme responsible for pain and inflammation.
The review considers available data up to December 31, 2005 from pre-clinical animal studies, clinical trials, scientific literature review, and Canadian and international post-marketing safety reports.
For the first time, a report summarizing the evidence and analyses involved in such a review process is being shared with the scientific community and the general public.
Based on the findings of the review, Health Canada has already taken regulatory action on other COX-2 drugs. Stronger warnings about cardiovascular risks have been added to the labelling of Celebrex. Similar labelling changes have been recommended for most NSAIDs. Bextra has been removed from the market.
Part of the information considered in the review process was the advice provided by Health Canada's COX-2 Expert Advisory Panel. The Department is today also releasing its comments on the panel's report. The panel of nine external experts was convened in June 2005 by Health Canada to provide advice and insight into the safety of COX-2 drugs, and received input through a public forum held June 9, 2005.
The following are among the actions Health Canada has already taken or will take on COX-2 drugs:

Vioxx and Bextra will not be returning to the Canadian market unless a New Drug Submission is received and approved by Health Canada;
Unbiased drug information is being provided directly to Canadians through Summary Basis of Decision documents and the MedEffect website; and
The Department is organizing a panel of external experts and consulting with Canadians about disclosing the registration and results of drug clinical trials.

Health Canada is also in the process of updating its guidance document for industry, Basic Product Monograph Information for Non-steroidal Anti-Inflammatory Drugs. This document will reflect the revised cardiovascular safety precautions and warnings that will be required on most non-selective NSAIDs on the Canadian market.
A summary of the evidence, analyses and recommendations of Health Canada's scientific review can be found on the Health Canada website in the Report on the Cardiovascular Risks Associated with COX-2-Selective Inhibitor NSAIDs.
The official comments from Health Canada on the advice provided by the COX-2 Expert Advisory Panel has also been posted on the website, in Health Canada Comments on the Report from the Expert Advisory Panel on the Safety of COX-2 Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
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Media Enquiries:
Christopher Williams
Health Canada
(613) 946-4250
Erik Waddell
Office of Minister Clement
Minister of Health
(613) 957-0200
Public Enquiries:
(613) 957-2991
1-866-225-0709

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Health Canada comments on expert panel report, releases COX-2 scientific review

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