Advisory
2004-67
December 17, 2004
For immediate release
Updated safety information on increased cardiovascular risk with Celebrex* (celecoxib)
OTTAWA - 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for the prevention of recurrence of Familial Adenomatous Polyposis is withdrawn, effective today.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.
|
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_e.html
-30-
Media Inquiries:
Media Relations
Health Canada
(613) 957-2983
Public Inquiries:
(613) 957-2991
|
