News Release

2005-75
July 7, 2005
For immediate release

Health Canada responds to Expert Advisory Panel on COX-2 drugs

OTTAWA - Health Canada today responded to the release of the report of the Expert Advisory Panel on selective COX-2 non-steroidal anti-inflammatory drugs (NSAIDs). The panel issued its recommendations earlier today.

"We welcome the panel's report and I'd like to thank the public for its contribution," Health Minister Ujjal Dosanjh said. "This is the first time that the Canadian public has been invited to participate in a Health Canada expert advisory panel. Health Canada supports the direction of the Panel's recommendations. Openness and transparency will become a way of doing business in the Department. For example, the Department announced this week that it would be holding a similar forum on the issue of market authorization for silicone gel-filled breast implants."

"I am not only impressed by the quality of the report, but also by the fact that the panel has made important suggestions that will further advance our plans for making important health and safety information more accessible," the Minister said.

Health Canada will immediately implement many of the panel's recommendations and we will work with our partners to see what further action can be taken.

Health Canada acknowledges the panel's view that, as a group, selective COX-2 inhibitors are associated with an increased risk of cardiovascular events, a risk that is similar to those associated with most NSAIDs. The panel noted that this risk is present for all patients taking anti-inflammatory agents and that it increases with longer-term use and when other risk factors, such as cardiovascular disease, are present.

Health Canada also acknowledges the panel's findings that certain drugs in this class are effective anti-inflammatory agents and that the use of these drugs should be left to informed patients, advised by their well-informed health care providers.

In the case of Vioxx, which is not currently authorized for sale in Canada, the panel reported that available data justifies the marketing of Vioxx in Canada because the risk of cardiovascular incidents from Vioxx appears to be similar to that of most NSAIDs. In order for VIOXX to be marketed in Canada, the manufacturer is required to submit a new drug submission to Health Canada. The submission would be carefully reviewed to ensure it meets safety data requirements, with particular attention to the safe labelling issues raised by the panel.

Immediate actions Health Canada will take include:

• Manufacturers of all NSAIDs currently on the market in Canada will be requested to provide updated patient safety information for these products. This would include Celebrex, which is currently available in Canada by prescription, and ibuprofen products currently available over-the-counter;
• Health Canada will continue its assessment of whether Bextra should be returned to the Canadian market after sales were voluntarily suspended in April 2005. The recommendations from the panel will be a key factor in the Department's final decision, which is expected in the coming weeks;
• Health Canada will be conducting further analysis and communicating to provincial health regulators the panel's recommendations on current over-the-counter availability of some ibuprofen products, in particular to address the possibility of inappropriate, long-term use of these products;
• Health Canada will issue guidance to manufacturers, establishing standards for the risk and benefit information that must be included in product labelling of NSAIDs.

"Health Canada's initiatives will not stop there," Minister Dosanjh said. "The public can rest assured that Health Canada will continue to act in the best interests of protecting the health of Canadians. Health Canada will also follow up on other recommendations made by the panel."

Over the longer term:

• Health Canada will continue to work with the Canadian Medical Association, the Canadian Pharmaceutical Association, The Arthritis Society, and other professional associations and consumer organizations to ensure that consistent safety information about NSAIDs is provided to health care professionals and the public;
• Health Canada endorses the panel's recommendation that all information associated with drug submissions and clinical trials be publicly available. The Minister has clearly stated his preference for full disclosure, with the exception of legitimate and compelling reasons of privacy or business confidentiality. This is the direction in which Health Canada will be moving;
• Health Canada will work with the Pharmaceutical Advertising Advisory Board to ensure safety information is appropriately reflected in advertising for this class of drugs;
• Health Canada will continue to strengthen cooperation with national associations of health care professionals to encourage and support the development of clinical practice guidelines describing the benefits and risks of COX-2 inhibitors and NSAIDs.

In line with the panel's recommendations on increased transparency of drug information, Health Canada has already undertaken the following initiatives:

• A recently completed public consultation on clinical trial registration and disclosure. Feedback gleaned from these consultations will be made public and will be used to help Health Canada develop options for facilitation the registration and disclosure of clinical trial information in Canada
• A new Web-based database on adverse drug reactions in Canada: http://www.hc-sc.gc.ca/dhp-mps/medeff/databasdon/index_e.html
• A discussion paper entitled, Designing a Mandatory System for Reporting Serious Adverse Reaction is posted on Health Canada's web site. The Department invites all interested stakeholders and the public to review the document and provide feedback. Face-to-face consultations with stakeholders and the public will be held late summer.

In the coming weeks, additional databases will be launched to increase Canadians' access to information on drug safety.

The panel, which met June 9-10, 2005 in Ottawa, was created by Health Canada to provide input and advice on the safety of COX-2 NSAIDs and was one part of an extensive review and study of research related to the safety of these drugs.

To access the report and for more information about the Panel, visit: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-consult/cox2/index_e.html

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