Archived – Updated safety information on increased cardiovascular risk with Celebrex (celecoxib)

Starting date:

December 17, 2004

Posting date:

December 17, 2004

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Product withdrawal, Product Safety

Audience:

General Public

Identification number:

RA-11000270

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Health Canada would like to inform patients using Celebrex^® (celecoxib) of increased cardiovascular risks when taken at daily doses

of 400 mg and 800 mg.

In Canada, the 800-mg daily dose of Celebrex® (celecoxib) received conditional approval in April 2002 for a rare genetic disease, Familial Adenomatous Polyposis, which is highly predictive of colorectal cancer. Other conditions for which the 400-mg daily dosage is approved include rheumatoid arthritis and management of acute pain.

New information was reported today demonstrating serious cardiovascular risks in one of two cancer prevention studies. This trial, which used 400-mg and 800-mg daily doses, was conducted by the National Cancer Institute in the United States. In this trial, the effect of Celebrex^® (celecoxib) was compared to placebo and the study showed increased risks for serious cardiovascular events. At the 400-mg daily dose, the risk was 2.5 times higher. For the 800-mg daily dose the risk was 3.4 times higher. Although the full analysis has not been transmitted to Health Canada, these events seem to be confined to acute heart attack, stroke and sudden cardiac death events.

The second trial, sponsored by Pfizer, used a 400-mg daily dose of Celebrex^® (celecoxib) and has not shown an increased risk for cardiovascular events to date. However, based on the results of the first trial, the use of Celebrex in both trials has been stopped.

Celebrex^® (celecoxib) should not be taken for the prevention of recurrence of Familial Adenomatous Polyposis and patients should discuss alternative therapeutic options with their doctors.

Health Canada also advises patients who are on long-term 400-mg daily doses of Celebrex^® (celecoxib) to discuss alternative therapies with their physician.

Health Canada has notified Pfizer that the market authorization for the use of Celebrex^® (celecoxib) for the prevention of recurrence of Familial Adenomatous Polyposis is withdrawn, effective today.

Health Canada will shortly issue further advice concerning the safety of selective COX-2 inhibitor NSAIDs.

If you have questions about your current prescription, please contact your physician or pharmacist.

If you have had a serious or unexpected reaction while taking Celebrex^® you may notify either Pfizer, or Health Canada as follows.

Any suspected adverse reaction can also be reported to:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Marketed Health Products Directorate

HEALTH CANADA

Address Locator: 0701C

OTTAWA, Ontario, K1A 0K9

Tel: 613-957-0337 or

Fax: 613-957-0335

To report an adverse reaction, consumers and health professionals may call toll free:

Tel: 866-234-2345

Fax: 866-678-6789

cadrmp@hc-sc.gc.ca

For other inquiries, please refer to contact information.

The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

• Report of Suspected Adverse Reaction due to Health Products Marketed in Canada (Vaccines excluded)
• Canadian Adverse Drug Reaction Monitoring Program (CADRMP) Guidelines for the Voluntary Reporting of Suspected Adverse Reactions to Health Products by Health Professionals and Consumers

Celebrex^® is a registered trademark.

Note: Health Canada issued another advisory on this topic on April 7, 2005. To access this advisory, visit: www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/2005/2005_17-eng.php.

 

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